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

Model Number FG540000

Device Problems Overheating of Device (1437); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that the patient underwent svt/avnrt (supraventricular tachycardia and atrioventricular nodal reentrant tachycardia) ablation procedures with a carto 3 system and a power leakage error (unknown code) when the ablation cable was connected to the piu (patient interface unit) occurred.The medical team disconnected everything from the front of the piu and reconnected the ablation cable without resolution.Upon inspection of the ablation cable, it was discovered that it appeared black on the inside of the connector of the cable that connects to the piu.The inside of the map port appeared burnt.The cable and catheter were replaced and the error cleared.Dispatch approved by css tb.Software version confirmed 7.2 (full code unknown).Connector/port problem is not mdr-reportable.Heat/thermal issue is mdr-reportable.

Manufacturer Narrative

On 13-jul-2023, the product investigation was completed.It was reported that the patient underwent svt/avnrt (supraventricular tachycardia and atrioventricular nodal reentrant tachycardia) ablation procedures with a carto 3 system and a power leakage error (unknown code) when the ablation cable was connected to the piu (patient interface unit) occurred.The medical team disconnected everything from the front of the piu and reconnected the ablation cable without resolution.Upon inspection of the ablation cable, it was discovered that it appeared black on the inside of the connector of the cable that connects to the piu.The inside of the map port appeared burnt.The cable and catheter were replaced and the error cleared.Device evaluation details: the reported current leakage error was caused by the disposables, and was resolved by the catheter cable and catheter replacement.Field service engineer (fse) replaced the backplane card, and the reported issue was resolved.The system was tested post repair, all testing passed.System is operational.The replaced backplane card was sent to device manufacturer for investigation/repair.Investigation was performed.The customer complaint "power leakage error and map port appeared burnt" was not confirmed.The connector is blackened due to water ingress.It's a mold, but not a signs of burning.During visual inspection the connectors map and 20 pole b were found slightly damaged.Those damages don't affect the ports functionality.Replacing damaged connectors map and pole b solved the discovered issue.A manufacturing record evaluation was performed for the finished device 14028 number, and no internal actions related to the complaint was found during the review.Manufacturing date: 02-may-2013.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17035120
• MDR Text Key: 316846102
• Report Number: 2029046-2023-01187
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ABLATION CATHETER.