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

Catalog Number	D133601
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch catheter, and an electrode temperature error was observed.Connections were checked and replaced but the problem was not resolved.When the catheter was replaced, the problem was not solved.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, force test and a scanning electrode microscope (sem) of the returned device were performed.Visual analysis revealed a separation between pebax's and the second electrode.In addition, a foreign material like a greenish-white and grainy texture, presumably corrosion, was observed in the second electrode.This finding is mdr reportable.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, force test and a scanning electrode microscope (sem) of the returned device were performed.Visual analysis revealed a separation between pebax's and the second electrode.In addition, a foreign material like a greenish-white and grainy texture, presumably corrosion, was observed in the second electrode.Then, the device was connected to the generator, and an ablation cycle was performed, and the device was found working correctly.No temperature or impedance issue was identified during the test.Due to the foreign material identified on the electrode, a sem test was performed and per the composition observed in the sample, the foreign material observed could be related to copper oxidation.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The pebax damage and corrosion identified during the analysis could be related to the temperature issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to manufacturing process.The potential cause of the foreign material cannot be established.The instructions for use (ifu) contain the following information: if the radiofrequency (rf) generator does not display the temperature, verify that the appropriate cable is plugged into the rf generator.If the temperature is still not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf energy.Concerning the pebax damage, the instruction for use (ifu) contains the following warnings and precautions: 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 hemostatic valve of the sheath.After insertion, slide the insertion tube back toward the handle.Do not scrub or twist the tip electrode because damage to the tip electrode bond may occur and loosen the tip electrode, or damage 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
• 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: 24186336
• Report Number: 2029046-2026-00312
• Device Sequence Number: 9513766
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: (01)10846835008982(17)280703(10)31693244M
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: D133601
• Device Lot Number: 31693244M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMARTTOUCH,TC,D,C3
• Patient Sex: Unknown