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

Catalog Number	D139401
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech for evaluation.Visual inspection, temperature and impedance test and irrigation test of the returned device were performed following johnson & johnson medtech procedures.Visual analysis revealed reddish material, presumably blood was observed inside the pebax.The temperature and impedance test were 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.The device tip was inspected under a microscope after performed the test, and a hole was found on the surface of the pebax section.A manufacturing record evaluation was performed for the finished device number lot 31562002l and no internal action related to the complaint was found during the review.The reddish material, presumably blood, inside the pebax could be related to the temperature issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the pebax hole could be related to the manipulation of the device during the procedure; however, it could not be determined.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.For the pebax hole the instruction for use states: 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 quality 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 a redo pulmonary vein isolation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax section.Initially, it was reported that during the procedure, when the physician tried to ablate with the qdot, the temperature values were increasing rapidly, ablation was automatically shut off and a ¿temperature slope too high¿ error message was shown on the ngen generator.Irrigation and pump were checked and found to be correct.Replacing the catheter cable did not solve the problem.Replacing the catheter solved the issue.Procedure completed without any patient consequence.The high temperature issue was assessed as non mdr reportable.The risk of patient harm is considered remote.The biosense webster, inc.Pal received the device and per the evaluation completion, a hole was observed on the pebax surface with reddish material inside.This was assessed as mdr reportable with an awareness date of 04-jun-2025.

• 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: 22352247
• Report Number: 2029046-2025-02112
• Device Sequence Number: 20964118
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(17)280219(10)31562002L
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: D139401
• Device Lot Number: 31562002L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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 CATHETER CABLE.; UNK_NGEN PUMP.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown