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

Catalog Number	D134702
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with thermocool smarttouch sf for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax surface.Initially it was reported that when connecting the catheter, there was a catheter sensor error message.The catheter was replaced and the issue resolved.No patient consequence.Additional information was received.Unsure which sensor failed (magnetic, force, temperature); however, it should be the error 106 - force sensor error.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-oct-2025, observed reddish material inside the pebax sleeve.Due to this condition, the device was inspected under microscope and it was found a hole on the pebax surface.The event was originally considered non-reportable, however, bwi became aware of a hole on the pebax surface on 07-oct-2025 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
Device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 30-sep-2025.Following j&j medtech procedures, a visual inspection and force test of the returned device were performed.Visual analysis revealed reddish material inside the pebax sleeve.Due to this condition, the device was inspected under microscope and it was found a hole on the pebax surface.The device was connected to the carto 3 system and no errors were observed.The force feature of the device was evaluated and the force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The carto 3 system instructions for use (ifu) contain the following information that should be considered: the force sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.For the damage on the pebax, the ifu states: do not scrub or twist the tip electrode as damage to the tip electrode bond may occur and loosen the tip electrode, or damage may also occur to the contact force sensor and affect measurement accuracy.As part of johnson & johnson medtech 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: 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: 23425436
• Report Number: 2029046-2025-03632
• Device Sequence Number: 18591513
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: (01)10846835009781(17)280729(10)31704480L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 10/30/2025

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: D134702
• Device Lot Number: 31704480L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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