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

Catalog Number	D139402
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a qdot micro catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the surface of the pebax.During the start of the ablation, there was a very strange behavior of the catheter.When starting, the ablation catheter jumped to another location but the catheter was in the same stable location.Interference of something? also, force went from 10 grams to 80 grams when starting.The neutral plate stuck on another location but the same behavior was during start of the ablation.The cable was replaced by a new one, but still the same issues.During these issues, no specific error.After replacing the catheter with a new one, the problem was solved.The procedure was delayed 15 minutes.Action taken was a new neutral plate, cable, new position, new catheter cable, and new catheter.The procedure was completed successfully.No patient consequences or patient issues.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2025 there was reddish material inside the pebax.A detailed inspection was performed and a hole in the surface of the pebax was found.The event was originally considered non-reportable, however, bwi became aware of a hole in the surface of the pebax on (b)(6) 2025 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 17-jul-2025.Following j&j medtech procedures, a visual inspection, force and magnetic test of the returned device were performed.Visual inspection revealed reddish material inside the pebax.A detailed inspection was performed and a hole in the surface of the pebax was found.The device was connected to the carto 3 system and it was recognized and visualized correctly.No visualization issue was observed.The force feature of the device was evaluated and the force values and the vector were observed within specifications.No force issues were observed.The force sensor error and jumping icon was confirmed as the reddish material inside the pebax could be related to the force and mapping issues reported by the customer.The potential cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following information: always zero the contact force reading following insertion into the patient or when moving the catheter from one chamber of the heart to another.Ensure the catheter is not in contact with heart tissue prior to zeroing.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.Refer to the user manual for your carto¿ 3 system for instructions on how to zero the contact force reading.A manufacturing record evaluation was performed for the finished device number lot 31572897l and no internal action related to the complaint was found during the review.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).

• 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: 22939313
• Report Number: 2029046-2025-02937
• Device Sequence Number: 10107289
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: (01)10846835017076(11)250215(17)280214(10)31572897L
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/02/2025

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: D139402
• Device Lot Number: 31572897L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2025
• 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.
• Patient Age: 69 YR
• Patient Sex: Male