MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCDH
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a navistar thermocool for which biosense webster¿s product analysis lab (pal) identified a broken tip.Initially, it was reported that during the operation, the tip of the device was found damaged.There were no wires being exposed, nor any lifted or sharp rings.A second device was used to complete the operation.There was no adverse event reported on patient.This was assessed as non mdr reportable.The risk of patient harm is considered remote.The biosense webster, inc.Pal received the device and per the evaluation completion on 19-feb-2025, the tip was partially detached from the device, with wires exposed.This was assessed as mdr reportable with an awareness date of 19-feb-2025.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection of the returned device was performed following j&j medtech procedures.Visual inspection revealed a bent at the tip of the device.In a microscope evaluation, it was observed that the tip was partially detached from the device, with wires exposed.A manufacturing record evaluation was performed for the finished device number lot and no internal actions related to the complaint was found during the review.The tip damage reported by the customer was confirmed.The potential cause of the damage could be related to the manipulation of the device during or after the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following information: do not use if the package is opened or damaged.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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).

• Brand Name: NAVISTAR THERMOCOOL
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 21639927
• Report Number: 2029046-2025-00832
• Device Sequence Number: 17819112
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)271029(10)31484171M
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: NI75TCDH
• Device Lot Number: 31484171M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown