MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133602
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 thermocool® smart touch¿ electrophysiology catheter and the spring of the catheter was broken.The issue was identified before the device had been inserted into the patient's body.The abnormality occurred when attempting to flex the catheter.Controlling it at the handle did not allow the catheter to flex, and the spring's condition appeared unusual.No further details were provided regarding completion of the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
On 29-jul-2025, the bwi product analysis lab received the device for evaluation.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
On 11-aug-2025, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the spring of the catheter was broken.The issue was identified before the device had been inserted into the patient's body.The abnormality occurred when attempting to flex the catheter.Controlling it at the handle did not allow the catheter to flex, and the spring's condition appeared unusual.No further details were provided regarding completion of the procedure.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual inspection revealed no damage or anomalies on the device.The tip and pebax was observed within specifications.A manufacturing record evaluation was performed for the finished device lot number: 31411574m and no internal action related to the complaint was found during the review.The pebax broken issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product complaint 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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 22461142
• Report Number: 2029046-2025-02241
• Device Sequence Number: 21039437
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)270815(10)31411574M
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P030031/S053
• 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): 09/04/2025

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: D133602
• Device Lot Number: 31411574M
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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_PREFACE SHEATH.
• Patient Sex: Unknown