MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	F5ADP282RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia procedure with a webster and the tip was damaged/broken issue occurred.Device damaged.It was reported that during the procedure, the tip of the catheter was broken (as the photos show) when it was inserted into the 6f sheath.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received on 18-aug-2024.The tip was damaged/broken.Internal mechanism exposed.There was a crack at the tip.There was no lifted or damaged electrodes.
Additional Manufacturer Narrative
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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 10-sep-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia procedure with a webster.Device damaged.It was reported that during the procedure, the tip of the catheter was broken when it was inserted into the 6f sheath.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received.The tip was damaged/broken.Internal mechanism exposed.There was a crack at the tip.There was no lifted or damaged electrodes.The device evaluation was completed on 17-sep-2024.The device was returned to the biosense webster, inc.For evaluation.A visual inspection evaluation of the returned device was performed following biosense webster, inc.Procedures.Visual analysis of the returned sample revealed that the tip of the device was broken, with wires exposed, and stress marks were identified.No other damage or anomalies were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The broken tip issue reported by the customer was confirmed.The potential cause of the condition observed in the device could be related to the excessive force or manipulation of the device during the procedure as stress marks were observed in the broken area; however, this can not be conclusively determined.As part of the biosense webster, inc.Quality process, all devices are manufactured, inspected, and released to approved specifications.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: WEBSTER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20173900
• Report Number: 2029046-2024-03001
• Device Sequence Number: 8069827
• Product Code: LDF
• UDI-Device Identifier: 10846835000467
• UDI-Public: (01)10846835000467(17)270221(10)31269160M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: F5ADP282RT
• Device Lot Number: 31269160M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 09/17/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/17/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK 6F SHEATH
• Patient Sex: Unknown