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

Catalog Number	D139501
Medical Device Problem Codes	Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a pulmonary vein isolation (pvi) ablation procedure with a qdot micro¿ catheter and temperature titration occurred frequently.The ablation was stopped due to the temperature rose.This occurred after approximately 80 ablations.Flushing was conducted, but the char was attached to the catheter and could not be removed by wiping it off by hand.The issue was resolved by replacing the qdot micro catheter.No patient consequences were reported.
Additional Manufacturer Narrative
On 27-feb-2025, bwi received additional information regarding the event.The irrigation issue was noted after pulmonary vein isolation ablation.Furthermore, on (b)(6) 2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a qdot micro¿ catheter and temperature titration occurred frequently.The ablation was stopped due to the temperature rose.This occurred after approximately 80 ablations.Flushing was conducted, but the char was attached to the catheter and could not be removed by wiping it off by hand.The issue was resolved by replacing the qdot micro catheter.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection, irrigation and temperature and impedance test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.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 for the finished device number 31448705l, and no internal action related to the reported complaint were identified.The high temperature, irrigation and char issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The instructions for use (ifu) 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 body.¿monitoring the temperature from the electrode during the application of rf energy ensures that the irrigation flow rate is being maintained.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product complaint 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).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21471752
• Report Number: 2029046-2025-00576
• Device Sequence Number: 3652570
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: 10846835016710
• 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,Followup
• Report Date (Section B): 03/21/2025

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: D139501
• Device Lot Number: 31448705L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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
• Patient Sex: Unknown