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

Catalog Number	D139401
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified that the tip was broken at the transition with the peek housing.During the procedure toward the end of the case, blood was noticed inside the clear tip of the catheter.The case was able to be completed without replacing the catheter.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.Visual inspection of the returned device was performed following j&j medtech procedures.Visual analysis revealed that the tip was broken at the transition with the peek housing, adhesive residues were observed at the area, no manufacturing deficiencies were found, additionally, reddish material around the transition and inside the pebax was observed, however, no damage in the pebax was found.The broken tip issue may have allowed the reddish material to enter all the way to the pebax area; therefore, it could be related to the issue reported.A manufacturing record evaluation was performed for the finished device 31444115l number, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax and broken tip issues could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the broken tip could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instruction for use states: do not scrub or twist the tip electrode as damage to the tip electrode bond may occur and loosen the tip electrode, or damage may also occur to 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.This product issue will be addressed through j&j medtech¿s quality system.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: 22097777
• Report Number: 2029046-2025-01723
• Device Sequence Number: 15292891
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)240905(17)270904(10)31444115L
• 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): 05/28/2025

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: D139401
• Device Lot Number: 31444115L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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
• Patient Sex: Unknown