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

Catalog Number	D139403
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and force test of the returned device were performed.Visual inspection revealed that there was a reddish material and a hole on the pebax surface.The device was connected to carto 3 system, and no errors were 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.A manufacturing record evaluation was performed for the finished device number lot 31378093l and no internal actions related to the complaint were found during the review.The force vector inverted issue reported by the customer could be related to the reddish material found on the pebax, therefore, the issue reported was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.The carto® 3 system instructions for use (ifu) contain the following information: -the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.-concerning the pebax damage, the instruction for use (ifu) contains the following warnings and precautions: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostatic valve of the sheath.After insertion, slide the insertion tube back toward the handle.Do not scrub or twist the tip electrode because damage to the tip electrode bond may occur and loosen the tip electrode, or damage to the contact force sensor and affect measurement accuracy.As part of johnson & johnson medtech's process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j's 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).
Event or Problem Description
It was reported that the patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, the catheter force vector displayed inappropriately and inverted despite multiple attempts to zero the catheter.No errors were displayed.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The case continued.No patient consequences were reported.

• 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: 21231106
• Report Number: 2029046-2025-00256
• Device Sequence Number: 18293443
• Product Code: OAE
• UDI-Device Identifier: 10846835017106
• UDI-Public: (01)10846835017106(11)240710(17)270709(10)31378093L
• 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
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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: D139403
• Device Lot Number: 31378093L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown