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

Catalog Number D139505

Device Problem Insufficient Cooling (1130)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter phone: (b)(6).The device was returned to biosense webster (bwi) for evaluation.Visual inspection, patency, temperature, and impedance tests of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The temperature and impedance test were 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 reddish material on the pebax could be related to the issue reported by the customer, however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The root 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 contain the following recommendations: in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn, and the tip electrode inspected for coagulum before radiofrequency (rf) energy is reapplied.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a qdot micro¿ catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially, it was reported that there was a sudden increase in temperature during ablation.The ¿red liquid¿ has been localized in the catheter tip.No consequences for the patient were reported.To complete the procedure, the physician used another product of the same type.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The high temperature issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 24-jan-2024, there was a reddish material and a hole in the pebax.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2024.

• 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: 18713323
• MDR Text Key: 336420768
• Report Number: 2029046-2024-00508
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31163179L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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