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

Catalog Number D139401

Device Problems Contamination (1120); Insufficient Cooling (1130)

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

Event Date 08/08/2023

Event Type  malfunction  

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 on the pebax with internal parts exposed.Initially, during the procedure, "temperature slope too high," was displayed and the ablation was stopped immediately.There was blood commingling at the 2nd and 3rd at the electrode when the catheter was checked.The issue was resolved by replacing the qdot micro catheter.The ngen generator was used.No other generator was used.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 27-sep-2023, reddish brown material was inside and a hole on the pebax with internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax with internal parts exposed on (b)(6) 2023 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 (b)(6) 2023.The device evaluation was completed on 27-sep-2023.The product was returned for evaluation.Biosense webster (bwi) conducted a visual inspection, temperature, impedance, and patency flow test of the returned device.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed; however, the hole could be related to the handling but, it cannot be conclusively determined.Temperature, impedance, and patency testing were performed per bwi procedures.The catheter temperature, impedance, and patency were working correctly and within specifications.No malfunction was observed.Scanning electron microscope (sem) conclusion indicates evidence of mechanical damage and a hole on the pebax surface.The event described was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issues.To minimize the temperature issue, the following guidelines should be followed: monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.A manufacturing record evaluation was performed for the finished device 31047880l number, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 18011691
• MDR Text Key: 326618779
• Report Number: 2029046-2023-02435
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139401
• Device Lot Number: 31047880L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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: UNK_NGEN RF GENERATOR