MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D132705
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: the expiration date and manufacture date are currently not available.Therefore, the full udi is currently not available.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 smarttouch sf and the physician couldn't get the catheter out of the sheath easily.When they checked the ablation catheter, there was a small bump on the catheter close to the electrodes.No further details were provided regarding troubleshooting of the event or completion of the procedure.No patient consequences or procedural delays were reported.
Additional Manufacturer Narrative
Per internal review on 10-mar-2026, it was determined that the h6 medical device problem code a0411 (material protrusion / extrusion) does not apply to this event with the information available, and that the initial report requires this correction.The information available does not provide a clear depiction of the actual state of the electrode or if any electrode damage was noted.Follow-up information was requested from the customer.However, in the meantime, there will be no further reports regarding this event as this event is not fda-reportable with the current information.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 16-apr-2026, the product investigation was completed and the identified findings indicated that the h6 medical device problem code a0411 (material protrusion / extrusion) does apply and this event is now fda-reportable.On 22-apr-2026, bwi received additional information indicating that the electrode itself was lifted, 'more smooth lifted than sharp'.The product investigation confirmed the lifted electrode finding and those details are captured below.It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf and the physician couldn't get the catheter out of the sheath easily.When they checked the ablation catheter, there was a small bump on the catheter close to the electrodes.No further details were provided regarding troubleshooting of the event or completion of the procedure.No patient consequences or procedural delays were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and dimensional test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed that the second electrode was found lifted.A dimensional test was performed, and the results were found within specifications.A manufacturing record evaluation was performed for the finished device 31830028m number, and no internal action related to the reported complaint condition were identified.The electrode damage reported by the customer was confirmed.The potential cause of the electrode condition could be related to the interaction with the sheath during 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 during catheter manipulation through the sheath.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: THERMOCOOL SMARTTOUCH SF
• 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: 24477447
• Report Number: 2029046-2026-00673
• Device Sequence Number: 21401933
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/07/2026

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: D132705
• Device Lot Number: 31830028M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/10/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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