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

Catalog Number	D139402
Medical Device Problem Codes	Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
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 medtech) for evaluation.Following j&j medtech procedures, a visual inspection and magnetic functionality test of the returned device were performed.Visual inspection revealed that there was reddish material and a cut on the pebax surface.The device was connected to carto 3 system, and no errors were observed.A manufacturing record evaluation was performed for the finished device number lot 31579014l and no internal actions related to the complaint were found during the review.The visualization & noise issue reported by the customer could be related to the reddish material found on the pebax, therefore, the issue reported was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain (ifu) the following recommendations in the carto 3 system manual: improperly positioned patches may increase the chances of a virtual magnetic reference move which is unrelated to patient movement.This could also result in inaccurate catheter visualization.- concerning the pebax damage, the catheter 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.As part of johnson & johnson medtech's process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j'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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a cut on the surface of the pebax.During the procedure at the start of ablation, the qdot in the carto mapping system began to move randomly.After replacing the return electrodes and checking whether a location patch was making contact with the return electrode, the problem recurred.After replacing the catheter cable, the problem persisted.The catheter was replaced.There was a total 20 minutes of troubleshooting that had occurred.The procedure was successfully completed using an stsf catheter.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 ; 3035526892
• MDR Report Key: 23320891
• Report Number: 2029046-2025-03465
• Device Sequence Number: 10637279
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: (01)10846835017076(11)250304(17)280303(10)31579014L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: D139402
• Device Lot Number: 31579014L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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; QDOT MICRO CATHETER; THERMOCOOL SMARTTOUCH
• Patient Sex: Unknown