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

Catalog Number D139501

Device Problem Insufficient Cooling (1130)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a qdot micro catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.Initially it was reported that at the beginning of the first ablation with qmode+, ¿temperature too high¿ or ¿temperature too delta high¿ occurred continuously.The cable was replaced but the issue continued.This error disappeared by replacing the qdot micro catheter to another new one.Temperature cut-off value was 65.Approximate temperature at the time of failure was 64.The ngen rf generator, japan was used.No other generator was used.The ablation never continued beyond the temperature cut-off value.The procedure was completed without patient's consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 09-feb-2024, a hole on the surface with reddish material inside the pebax was observed.This event was originally considered non-reportable, however, bwi became aware of a hole on the surface of the pebax on 09-feb-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 24-jan-2024.The device evaluation was completed on 09-feb-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, patency, temperature and impedance test of the returned device were performed following bwi procedures.Visual inspection was performed and a hole on the surface with reddish material inside the pebax was observed.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.The hole on the surface could be related with the manipulation of the device during the procedure; however, this can not be conclusively determined.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 foreign material inside the pebax could be the root cause of the high temperature reported by the customer.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer¿s reference number: (b)(4).

• Brand Name: QDOT MICRO
• 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: 18847268
• MDR Text Key: 337673311
• Report Number: 2029046-2024-00745
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: 10846835016710
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139501
• Device Lot Number: 31155694L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• 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
• Treatment: NGEN RF GENERATOR, JAPAN; UNK CABLE