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

Catalog Number	D134805
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 force test of the returned device were performed.Visual inspection identified a reddish material, presumably blood, and a hole in the surface of the pebax.The device was connected to the carto 3 system, and it was recognized; error 106 displayed on screen.Due to this condition, the handle of the device was dissected, and resistance of the sensor pads on the printed circuit board (pcb) was measured and the results were found out of specifications.A dissection was performed at the tip area and an open circuit was identified.In addition, further investigation of the peek housing section revealed that there was adequate adhesive on the wires.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The force issue reported by the customer was confirmed.The reddish material inside the pebax could be related to the issue reported by the customer.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The potential cause of the open circuit could not be determined.The carto® 3 system instructions for use (ifu) contain the following information: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.An internal action was initiated to investigate potential manufacturing process factors related to customer complaints of force sensor error 106 caused by a force sensor disconnection.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 hole in the pebax identified by bwi pal.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer's reported force sensor errors.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch sf for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that there was a force sensor error.There were no patient consequences.The customer's reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 14-may-2026, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax and a reddish material inside the pebax.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 25466011
• Report Number: 3013300026-2026-01823
• Device Sequence Number: 13342750
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(17)280930(10)31761827L
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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

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: 31761827L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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