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

Catalog Number	D139504
Medical Device Problem Code	Erratic or Intermittent Display (1182)
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 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, was recognized and visualized properly, and no errors were observed.A manufacturing record evaluation was performed and no internal action related to the reported complaint condition were identified.The jump 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 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 report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure and whenever ablation was started, the qdot micro¿ catheter would jump up on the screen of the carto® 3 system and appear moving when it was in the same location according to fluoroscopy.The cable was replaced without resolution.The qdot micro¿ catheter was replaced, and the problem was resolved.The case continued.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.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 a reddish material and a cut on the pebax surface.This finding is mdr reportable.

• 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: 23355103
• Report Number: 2029046-2025-03514
• Device Sequence Number: 21057810
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250130(17)280129(10)31552751L
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 31552751L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: UNK CABLE.; UNK_CARTO 3.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown