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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER INC CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number FG540000
Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. (b)(4).
 
Event Description
It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto 3 system. There was a map shift. During atrial fibrillation procedure after inserting heliostar in the patient, temperature were jumping on generator, lot of noise on heliostar, changed cable from heliostar balloon to ngen generator, did not solve the issue. Then changed the balloon itself, after that error 201 "console malfunction error". Rebooted the system and changed cable m581006, and the issue was sorted. Visualization issue of the balloon, in the middle of the balloon, was stripped, had a very good matrix, visualization not aligned with the xray system, saw a clear map shift without error message. No patient consequences reported. Additional information: catheter projection not aligned with xray. The issue was seen after mapping, mapping was performed with different catheter (lassonav). No cvn, no patient movement. No ablation was possible. Need to change the cable. No ablation above cut off. All electrode 1-10 experienced the temperature cut-off. Map shift is mdr-reportable.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
MDR Report Key12636702
MDR Text Key281991974
Report Number2029046-2021-01759
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
Treatment
HELIOSTAR BALLOON; NGEN RF GENERATOR
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