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	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and temperature and impedance test of the returned device were performed following j&j medtech procedures.Visual analysis revealed a hole in the surface of the pebax.No foreign external material inside the pebax, with internal parts exposed, no other damage were detected on the device during the analysis.The device was connected to the carto 3 system and the generator; the device was recognized and visualized correctly.An ablation cycle was performed and the device was found working correctly.No temperature issues were observed.A manufacturing record evaluation was performed for the finished device 31598246l number, and no internal actions related to the reported complaint condition were identified.The hole in the surface of the pebax could be related to the temperature sensor issue 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.About the pebax damage, the instruction for use (ifu) contains the following warnings and precautions do not use excessive force to advance or withdraw the catheter when resistance is encountered.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.Do not use this catheter with a long sheath or short introducer < 8.5 f in order to avoid damage to the catheter shaft.The instruction for use (ifu) contains the following warnings and precautions: monitor the catheter tip temperature response throughout the procedure to ensure adequate irrigation.If temperature increases very rapidly during rf application, power delivery should be interrupted.The irrigation system must be rechecked prior to restarting rf (radiofrequency) application.Note: the displayed temperature represents the temperature of the electrode only, not the temperature of the tissue.When rf energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip should be inspected for char/coagulum that may be present on the tip.If present, do not continue the procedure with the same catheter and replace the catheter.If no char/coagulum is present, flush the tip to ensure the irrigation holes are not plugged prior to reinsertion of the catheter inside the patient body.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 the 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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, the medical team lost the heat map on the carto® 3 system, and no errors were displayed.The cable was replaced without resolution.The tx eco cable was replaced, but the issue remained.The qdot micro¿ catheter was replaced, but the issue still there.The case continued without the heat map.No patient consequences were reported.

• 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: 23048806
• Report Number: 2029046-2025-03146
• Device Sequence Number: 13217639
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250312(17)280311(10)31598246L
• 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): 09/15/2025

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: 31598246L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: CARTO 3 SYSTEM.; NGEN RF GENERATOR.
• Patient Sex: Unknown