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

Model Number FG540000

Device Problems Fire (1245); Communication or Transmission Problem (2896)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a fire hazard issue occurred.The carto® 3 system would not recognize the mapping catheter.Upon inspection the pins appeared burnt in the mapping port.No smoke or fire was observed.There was no patient consequence reported.The recognition issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The issue of the pins appeared burnt in the mapping port was assessed as mdr reportable for a fire hazard issue.

Manufacturer Narrative

The investigation was completed on 11-jul-2022.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.The carto® 3 system would not recognize the mapping catheter.Upon inspection the pins appeared burnt in the mapping port.No smoke or fire was observed.There was no patient consequence reported.It was confirmed that the issue was resolved by replacing the faulty backplane with another one that was delivered to the customer.The issue was resolved.Replaced backplane was sent to the device manufacturer for investigation and repair.The customer complaint "it was reported that the ablation catheter appeared to be jumping all over the carto map¿ was confirmed.During visual investigation was found that the cause of the issue was a defective connector j27(map) on the backplane card.It was found corrosion in connector j27(map).Also, found marcs of corrosion in connector j38 (uls).Replaced connectors j27(map) and j38 (uls), on backplane card solved the issue.The system is ready for use.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system # 11117, and no internal actions related to the reported complaint condition were identified.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13728452
• MDR Text Key: 286986632
• Report Number: 2029046-2022-00511
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2010
• 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