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	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 30-jun-2025.Following j&j medtech procedures, a visual inspection, irrigation and temperature and impedance test of the returned device were performed.Visual inspection revealed reddish material, presumably blood inside the pebax section; additionally, a hole on the surface of the pebax was identified, without exposed wires; no other issues or anomalies were detected during the visual inspection.The device was connected to the generator and an ablation cycle was performed and the device was found working correctly.No temperature or impedance issues were observed.An irrigation test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.Since reddish material and the hole were found during the analysis, the high temperature reported was confirmed, the failure found could be related to the reported event by the customer.The potential cause of the damage, could be related to the use of the device during the procedure; however, this could not be conclusively determined.The instructions for use (ifu) in relation to the high temperature; contain the following information: 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¿s body.In accordance to the reddish material found, 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 & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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 for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.Temperature sensor error (temperature too high while ablating) issue occurred.The procedure was not delayed due to the reported event.No patient consequence.Additional information was received.The temperature cut off value was exceeded; however, the system did stop the ablation.It was qmode+ and 55 degrees threshold.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 11-jul-2025, observed reddish material, presumably blood inside the pebax section.Additionally, a hole on the surface of the pebax was identified, without exposed wires.The event was originally considered non-reportable, however, bwi became aware of a hole on the surface of the pebax on 11-jul-2025 and have assessed this returned condition as 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: 22745277
• Report Number: 2029046-2025-02618
• Device Sequence Number: 7534226
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(11)250207(17)280206(10)31559823L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/07/2025

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: 31559823L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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 GENERATOR
• Patient Sex: Unknown