MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problem No Pacing (3268)

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

Event Date 10/08/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a pacing issue during emergency use occurred.The carto® 3 system did not pace from the emergency port.Continued cases by exchanging hospital backup cable.There was no patient consequence reported.Additional information was received on 10-oct-2021.The event occurred during the procedure.Pacing could not be conducted from the emergency port at the carto procedure and was continued with changing to the hospital back up cable.The procedure was successfully completed without patient's consequence.Additional information was received 01-nov-2021.This was for emergency pacing.The pacing leads were connected to the primary pacing port.The carto® did not allow pacing and ablating at the same time.The (b)(6) co., ltd pacing stimulator was used during the procedure.There was no unwanted pacing delivered.The pacing issue during emergency use was assessed as a mdr reportable malfunction.

Manufacturer Narrative

(b)(6).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).

Manufacturer Narrative

The investigation was completed on 02-jan-2022.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a pacing issue during emergency use occurred.The carto® 3 system did not pace from the emergency port.Continued cases by exchanging hospital backup cable.There was no patient consequence reported.It was reported that during troubleshooting, it was found that the defective jb pacing auxilary cable caused the issue.The defective jb pacing auxilary cable was replaced with a hospital backup cable and the issue was resolved.Technical services confirmed that a replacement jb pacing auxilary cable was provided to the customer.Issue is resolved.The system is in service and ready for use.It was requested to send the defective jb pacing auxilary cable for investigation to the device manufacturer.However, the biosense webster, inc.Representative reported that the defective cable had already been scrapped.Therefore, the cable was not investigated.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.A manufacturing record evaluation was performed for the carto 3 system # 50032, 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: SIMILAR DEVICE FG540000, 510K # K042999
• 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 ; IS
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12760581
• MDR Text Key: 285952000
• Report Number: 2029046-2021-01896
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• 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