Biosense Webster Carto 3 User Manual

Posted : admin On 10/7/2021

Service Manual is available on request It is strongly recommended that the Operator reads the User Instruction Manual document in its entirety and is familiar with its contents before using the Stimulator on patients. 1.1.3 Intended Use The Micropace Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the. Aug 22, 2010  From Biosense Webster. The CARTO 3 System is the next generation magnetic tracking 3D mapping system from Biosense Webster, building on the accuracy of CARTO System magnetic navigation technology. In February 2012, the MHRA issued a field safety notice for this device. Find out more here.

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CFR Title 21Radiation-Emitting ProductsX-Ray AssemblerMedsun ReportsCLIATPLC

Model Number M-4800-01
Event Date 08/30/2011
Event Type Malfunction
Manufacturer Narrative

(b)(4). The carto manufacturer received a copy of the data related to the issue, but couldn't investigate it because 50% of the recordings were missing due to some action done when the data was copied. There was no option to retrieve the entire related data. Therefore, the complaint analysis was concluded based on the available information. The reported issue is related to (b)(4). However, map shift event is highly detectable and probability of occurrence of a serious injury and/or death from map shift is very remote. Complaint condition was confirmed.

Event Description

It was reported that the carto 3 rmt suffered a map shift during an afib procedure. Navigant was not in use for this case. The shift was identified by fluoro and ultrasound. The physician believes that the map shift occurred, but the clinical staff did not. No errors were displayed on the carto. Case recordings and debug files will be copied for analysis. Referred to fse.

Manufacturer Narrative

Additional information from customer (affiliate): no warning message from carto. Fluoro position the same. We did a cardioversion on patient however system looked like it compensated. Not sure how many mm we had movement. However i confirmed placement with uls but physician still insisted there was a map shift. This was a carto 3 used in conjunction with odyssey. Rmt was not in use for this case. The physician created a manual shell with the lasso catheter. Acl function in use. Physician expressed concern of map shift relative to catheter and his position on fluoro. Cardioversion was performed and the system did not indicate a patient and or patch movement. The mapping, lasso and cs catheters were connected to the piu. Per physician, the acl catheter shifted, and they did not use rmt catheter. (b)(4).

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Biosense Webster Ep Catheters

Manufacturer (Section D)
4 hatnufah st.
yokneam 2069 2
IS 20692
Manufacturer (Section G)
4 hatnufah st.
yokneam 2069 2
IS 20692
Manufacturer Contact
jaime chavez
15715 arrow highway
irwindale , CA 91706
MDR Report Key2250467
Report Number9681484-2011-00019
Device Sequence Number1
Product CodeDQK
Report Source Manufacturer
Source TypeUser facility
Reporter Occupation
Type of ReportInitial,Followup
Report Date08/30/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device MODEL NumberM-4800-01
Device Catalogue NumberFG540000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/30/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Type of Device Usage Reuse

Biosense Webster Carto 3 System

  1. Biosense Webster, Inc (BWI) has identified vulnerabilities with existing mitigations in BWI’s Carto®3 system associated with SMBv1 as used in recent Wannacry ransomware attacks. BWI is developing a cybersecurity update to address these vulnerabilities. Mitigating controls for customers are already in.
  2. Biosense Webster, Inc. (BWI) has produced a software update that applies operating system patches and anti-virus signature updates to close known vulnerabilities in the operating system of the CARTO® 3 System. This update will be applied to CARTO® 3 Systems starting in April 2018, as part of the free-of-charge CARTO® 3 Version 6 (V6) base.