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

Catalog Number	D134805
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j) for evaluation on 07-apr-2026.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 reddish material inside the pebax, a lifted electrode slid down and internal components were exposed leaving a hole in the surface of the pebax.Also, proper manufacturing assembly was observed on the electrode damaged.A dimensional test was performed in the rest of the electrodes, no damage was observed and the results were found within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The tip and resistance issue reported by the customer was confirmed, as the physical condition of the tip of the device could be related to the reported event.The potential cause of these issues could be related to the interaction between the catheter and sheath during the procedure; however, this can not be conclusively determined.The catheter instructions for use (ifu) contains the following recommendations: 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, or may damage the contact force sensor.In addition, in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿manufacturing anomaly on the catheter tip¿ and ¿difficulty during insertion in the sheath¿ issues.In addition, biosense webster inc.Analysis finding of the ¿reddish material inside the pebax and a hole in the surface of the pebax¿.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿manufacturing anomaly on the catheter tip¿ and ¿difficulty during insertion in the sheath¿ issues.In addition, biosense webster inc.Analysis finding of the ¿lifted electrode slid down and internal components were exposed¿.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 catheter for which biosense webster¿s product analysis lab (pal) identified a lifted electrode slid down and internal components were exposed leaving a hole in the surface of the pebax.Initially it was reported that there was a manufacturing anomaly on the catheter tip.No patient consequence.Additional information was received which indicated that the damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was difficulty during insertion in the sheath.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2026, it was identified that there was reddish material inside the pebax, a lifted electrode slid down and internal components were observed exposed leaving a hole in the surface of the pebax.The event was originally considered non-reportable, however, bwi became aware of a lifted electrode slid down and internal components were exposed leaving a hole in the surface of the pebax on (b)(6) 2026 and have assessed this returned condition as reportable.

• 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: 25311268
• Report Number: 2029046-2026-01700
• Device Sequence Number: 20188484
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(17)281024(10)31776256L
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/27/2026

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: D134805
• Device Lot Number: 31776256L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2025
• 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