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

Catalog Number	D133602
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac procedure with a thermocool smarttouch for which biosense webster¿s product analysis lab (pal) identified a hole in the surface of the pebax.Initially, it was reported that there was an extremely high force reading were displayed, only when coming on with radiofrequency (rf) ablation.They unplugged, replugged, and changed the cable and the issue was not resolved.When the catheter was replaced, the issue was resolved.Once they withdrew the catheter from the body, they noticed there was blood inside the spring section of the catheter.There was no patient consequence.The foreign material (blood) and force issue were assessed as non mdr reportable.The risk of patient harm is considered remote.The biosense webster, inc.Pal received the device and per the evaluation completion on 28-jan-2025, reddish material and a hole in the surface of the pebax were noted.This was assessed as mdr reportable with an awareness date of 28-jan-2025.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and screening test were performed following j&j medtech procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The force feature was tested, and no errors were observed.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 number lot 31381350m and no internal actions related to the complaint were found during the review.The reddish material inside the pebax could be related to the foreign material and force issues reported by the customer; therefore, 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 instructions for use (ifu) of the carto 3 system contain the following recommendations: do not scrub or twist the tip electrode because damage to the tip electrode bond may occur and loosen the tip electrode, or damage the contact force sensor and affect measurement accuracy.As part of johnson and johnson medtech¿s 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.E1.Initial reporter phone: (b)(6).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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21256681
• Report Number: 2029046-2025-00281
• Device Sequence Number: 8093182
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)270722(10)31381350M
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/28/2025

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: D133602
• Device Lot Number: 31381350M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: UNK CABLE
• Patient Sex: Unknown