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

Catalog Number	D132705
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 screening test of the returned device were performed.Visual inspection revealed reddish material and a hole in the pebax.The device was connected to the carto 3 system and no errors were observed.The feature of the device was evaluated and no issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The damage in the pebax could be related to the hardware error issue reported by the customer, the complaint was confirmed.The potential cause of the damage on the pebax could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The instruction for use (ifu) of the device contains 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 & johnson medtech's 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 an idiopathic ventricular tachycardia 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 after mapping and performing some ablation, the physician stepped on the ngen pedal and catheter error 273 was displayed on the ngen generator.The catheter cable was replaced without resolution.The catheter was replaced, and the issue resolved.The customer's reported catheter error 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 29-may-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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22324917
• Report Number: 2029046-2025-02065
• Device Sequence Number: 15684476
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)271218(10)31531322M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: 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: D132705
• Device Lot Number: 31531322M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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: NGEN RF GENERATOR.; THMCL SMRTTCH,BI,NAV,TC,D-F,C3.
• Patient Sex: Unknown