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

Catalog Number	D139501
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 04-mar-2025.Following j&j medtech procedures, a visual inspection and magnetic sensor functionality test of the returned device were performed.Visual analysis revealed reddish material in the tip of the device.The device was connected to the carto 3 system and it was recognized and visualized correctly.No visualization issue or failures were observed.Further examination under microscopic imaging, a separation between the pebax and electrode area was found.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The recognition issue could be related to the reddish material found on the pebax; therefore, the customer complaint was confirmed.The root cause of the pebax separation could be traced to the manufacturing process.The instructions for use (ifu) states: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode, or may damage the contact force sensor.In addition, 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 hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.An internal corrective action has been opened to address manufacturing opportunities related to the force sensor sleeve insolation to prevent fluids to get inside into the device.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to manufacturing (d03)/ component code: sleeve (g04115) were selected as related to the customer¿s reported ¿catheter was not recognized¿ issue.In addition, biosense webster inc.Analysis finding of the ¿reddish material in the tip of the device and a separation between the pebax and electrode area.¿ -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿catheter was not recognized¿ issue.In addition, biosense webster inc.Analysis finding of the ¿manufacturing process¿ related.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a separation between the pebax and electrode area.The catheter was not recognized.Timing of connecting the catheter to the patient interface unit (piu).The issue was resolved by replacing the qdot micro catheter with another new one.The procedure was completed without patient consequence.Biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 27-mar-2025 observed reddish material in the tip of the device.Further examination under microscopic imaging, a separation between the pebax and electrode area was found.The event was originally considered non-reportable, however, bwi became aware of a separation between the pebax and electrode area on 27-mar-2025 and have assessed this returned condition as reportable.

• 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: 21876013
• Report Number: 2029046-2025-01250
• Device Sequence Number: 15419997
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)241001(17)270930(10)31461349L
• 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
• Report Date (Section B): 04/21/2025

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: 31461349L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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_CARTO 3
• Patient Sex: Unknown