MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139504
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and post procedure a bwi product analysis lab identified a hole in the pebax.During the procedure, while ablating with the qdot micro¿ catheter, the carto¿ 3 system displayed error 105, map: catheter sensor error.The cable was replaced without resolution.The qdot micro¿ catheter was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed.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 magnetic sensor functionality test of the returned device were performed.Visual analysis revealed a hole and reddish material inside the pebax.The device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors were observed.A manufacturing record evaluation was performed for the finished device number lot 31614953l and no internal actions related to the complaint were found during the review.The reddish material inside the pebax could be related to the magnetic sensor error reported by the customer; therefore, the customer 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 carto® 3 system instructions for use (ifu) contain the following information: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.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 reference number: (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 23099282
• Report Number: 2029046-2025-03221
• Device Sequence Number: 15607719
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250424(17)280423(10)31614953L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• 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
• Report Date (Section B): 09/19/2025

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: D139504
• Device Lot Number: 31614953L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: NGEN GENERATOR
• Patient Sex: Unknown