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

Catalog Number	D139505
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 force test of the returned device were performed.Visual inspection revealed reddish brown material inside the pebax and a hole in the pebax on the device.The device was connected to the carto 3 system and no errors were observed.The force feature of the device was evaluated and the force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device lot number 31656745l and no internal action was found during the review.The force issue reported by the customer was confirmed as the reddish material inside the pebax could be related to the force issue reported by the customer.The instructions for use (ifu) contain the following information: always zero the contact force reading following insertion of the catheter into the patient or when moving the catheter from one chamber of the heart to another.Ensure the catheter is not in contact with heart tissue prior to zeroing.Do not scrub or twist the tip electrode because damage to the tip electrode bond may occur and loosen the tip electrode, or damage to the contact force sensor and affect measurement accuracy.Refer to the instructions for use for the carto¿ 3 system for instructions on how to zero the contact force reading.The instructions for use (ifu) contain the following recommendations: 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.In addition, in order to prevent damage to the catheter tip, verify compatibility between the sheath and catheter, advance the catheter through the sheath prior to insertion.Any sheath < 8.5 f is contraindicated.As part of johnson and 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).
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 hole in the pebax.During the procedure, there was a contact force sensor error on the qdot.This occurred during right ventricular outflow tract (rvot) ablation, two hours after the qdot micro catheter use commenced.Reconnection of the cable and restart of the dongle did not resolve the issue.Cable replacement also failed to resolve the issue.The qdot was replaced and the procedure was subsequently completed.The procedure was completed without patient's consequence.

• Brand Name: QDOT MICRO
• 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: 24543008
• Report Number: 2029046-2026-00747
• Device Sequence Number: 12161844
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)250519(17)280518(10)31656745L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/09/2026

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: D139505
• Device Lot Number: 31656745L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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.; OPTRELL CATHETER.
• Patient Sex: Unknown