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

Catalog Number	D133602
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection, irrigation, temperature and impedance test of the returned device were performed following j&j procedures.Visual analysis revealed that a hole on the surface of the pebax with reddish material inside the pebax.The temperature and impedance test could not be performed as error 170 was displayed on the generator.Due to this condition, the handle of the device was dissected, and the resistance of the thermocouples (tc) pads on the connector printed circuit board was measured, and all measures were according to specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material inside the pebax could related to the temperature issue reported by the customer; therefore the complaint was confirmed.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 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that temperature can¿t display.There was no patient consequence.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 (b)(6) 2025, 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
• 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: 21407311
• Report Number: 2029046-2025-00456
• Device Sequence Number: 9345017
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)260629(10)31079559M
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,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 Expiration Date: 06/29/2026
• Device Catalogue Number: D133602
• Device Lot Number: 31079559M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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