MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131603
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and deflection test of the returned device were performed.Visual inspection revealed that the peek housing is cracked/broken; however, no sharp or lifted edges were observed.Exposed wires were observed at the damage section.Deflection testing was performed, and the deflection mechanism failed specifications due to the puller wire was found broken inside the handle.A manufacturing record evaluation was performed for the finished device on lot 31330706l, and no internal actions related to the reported complaint were identified.The deflection issue reported by the customer was confirmed.The potential cause for the broken puller wire could not be established.The instructions for use (ifu) contain the following information: adjust the radius of curvature as necessary by manipulating the thumb knob.Pushing the thumb knob forward causes the catheter tip to curve; pulling the thumb knob back straightens the catheter tip.The damage on the peek housing could be related to the handling of the device; however, the exact time when the damage appeared remains unknown since it was not reported by the customer, also, the damage on the peek housing is not related to the customer complaint.The instructions for use (ifu) contain the following information: when rf energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum, if present.When cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode.Make sure the irrigation holes are not plugged prior to re-insertion.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through the quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that the patient underwent a cardiac ablation procedure with a thermocool® sf uni-directional catheter and post procedure the bwi product analysis lab identified cracked/broken peek housing, exposed wiring, and a broken puller wire inside of the handle.During the procedure, the physician identified a broken pulling wire.They lost the ability to curve during the procedure.They replaced with a like device and completed the procedure.No patient consequences were reported.

• Brand Name: THERMOCOOL® SF UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22523945
• Report Number: 2029046-2025-02349
• Device Sequence Number: 15468361
• Product Code: LPB
• UDI-Device Identifier: 10846835009330
• UDI-Public: (01)10846835009330(17)270514(10)31330706L
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P030031/S034
• 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
• Report Date (Section B): 07/16/2025

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: D131603
• Device Lot Number: 31330706L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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