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

Catalog Number D139504

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the qdot micro device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis was performed, and reddish material was observed inside the pebax; evidence of separation between the sleeve and the electrode was observed.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, high force appeared due to an internal printed circuit board (pcb) issue.A manufacturing record evaluation was performed for the finished device 31172448l number, and no internal action was found during the review.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during procedure; however, this cannot be conclusively determined.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro¿ catheter and reddish material was observed inside the pebax.Evidence of separation between the sleeve and the electrode was observed.During the procedure, a qdot catheter had a catheter force sensor error (error#unknown) displayed on the carto® 3 system.The catheter was replaced and the issue was resolved.The case continued.No patient consequences were reported.

• Brand Name: QDOT MICRO¿ CATHETER
• Type of Device: 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: 19001926
• MDR Text Key: 339053282
• Report Number: 2029046-2024-01057
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139504
• Device Lot Number: 31172448L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1