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

Catalog Number	NR7TCSIY
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navistar rmt thermocool and the coating at the tip of the catheter was lifting.At the time of flushing, the coating at the tip of the catheter was lifting.Resolved by replacing the navistar rmt thermocool catheter to another new one.The procedure was completed without patient's consequence.Additional information was received on 26-feb-2025.The event occurred pre-op.Additional information was received on 27-feb-2025.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.The catheter was not inserted into the patient's body.The catheter was not pre-shaped.No sheath was involved in the alleged event.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 12-mar-2025.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 cardiac ablation procedure with a navistar rmt thermocool.At the time of flushing, the coating at the tip of the catheter was lifting.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.The catheter was not inserted into the patient¿s body.The catheter was not pre-shaped.No sheath was involved in the alleged event.The device evaluation was completed on 28-mar-2025.The device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed a bent mark in the tip of the device and no wires exposed were detected.No other damage or anomalies were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The bent condition observed could be related to the tip issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the bent mark could be related to the handling of the device before the procedure; however, this can not be conclusively determined.The catheter instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter when resistance is encountered.As part of the johnson & johnson medtech 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: NAVISTAR RMT 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: 21578552
• Report Number: 2029046-2025-00754
• Device Sequence Number: 9217897
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(17)270407(10)31257641M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2025

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: NR7TCSIY
• Device Lot Number: 31257641M
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 03/28/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/26/2025; 03/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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