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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation afib: paroxysmal ablation procedure, and when they came on ablation with the qdot micro¿ catheter, the force readings increased (jumped up) multiple times.There were no errors displayed.The cable was replaced without resolution.When the catheter was replaced, the issue resolved.The reporter noted that it was a brand-new catheter.The procedure continued with no further issues.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 screening test of the returned device were performed.Visual analysis revealed reddish material inside the pebax and a separation between electrode and pebax.This finding is mdr reportable.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and screening test of the returned device were performed following j&j medtech procedures.Visual analysis revealed reddish material inside the pebax and a separation between electrode and pebax.The device was connected to the carto 3 system, and it was recognized; however, error 106 was displayed on the screen due to an open circuit at the tip area.In addition, the device was dissected at the peek housing section and a correct adhesive application was observed on the wires.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The potential cause of the damage on pebax is related to the manufacturing process of the device.The potential cause of the open circuit could not be determined.The damage on the pebax is unrelated to the reported event.When using the qdot micro¿ bi-directional catheter with conventional systems (such as fluoroscopy or ultrasound imaging), or with the carto¿ 3 navigation system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement should be done under direct imaging guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care be taken to prevent perforation of the heart.The contact force reading is for information only and is not intended to replace standard handling precautions.The instruction for use states: do not scrub or twist the distal tip electrode during cleaning.Do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.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).

• 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: 24762324
• Report Number: 2029046-2026-01102
• Device Sequence Number: 21348093
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)251021(17)281020(10)31783776L
• 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): 04/02/2026

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: D139401
• Device Lot Number: 31783776L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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
• Patient Sex: Unknown