MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; 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 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The product was returned for evaluation.Biosense webster (bwi) conducted a visual inspection and screening 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.The force issue described was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue as a potential cause.The root cause of the damage could be related to the usage of the device during procedure; however, this cannot be conclusively determined.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.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent a persistent atrial fibrillation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.Initially it was reported that during the procedure during ablation, abnormal contact force occurred.Catheter unplugged and replugged and problem was unsolved.They changed the cable and the problem was also unsolved.They changed the catheter to a new qdot catheter and the problem resolved.The procedure was successfully completed.No clinical consequence for the patient.Lengthening of procedural time was approximately 5 minutes.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, there was reddish brown material 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) 2024 and have assessed this returned condition as reportable.

• 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: 18812574
• MDR Text Key: 337632505
• Report Number: 2029046-2024-00683
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 31146103L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• 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: UNKNOWN BRAND CABLE; UNK_NGEN RF GENERATOR