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

Catalog Number D139505

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)

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

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.Biosense webster (bwi) conducted a visual inspection, screening, 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.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.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.The events described were unable to be duplicated during the product investigation; however, the blood found inside the pebax area could be related to the reported issues.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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 31049049l 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.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 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 force and temperature sensor error.The procedure was completed when the physician used another product of the same type.There was no patient consequence reported.The force and temperature sensor issues were 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 27-sep-2023, the was reddish brown material inside and a hole on the pebax with internal parts exposed.This was assessed as mdr reportable.The awareness date for this reportable lab finding was 27-sep-2023.

• 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: 18012295
• MDR Text Key: 326624575
• Report Number: 2029046-2023-02419
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• 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: 10/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31049049L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1