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

Catalog Number D139402

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with two qdot micro catheters for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed on both devices.Initially it was reported that after the left pulmonary veins had already been blocked and the right veins were to be started, massive increases in contact force suddenly occurred during energy delivery.The catheter tip was inspected.The tip showed an entry of blood.Therefore, the catheter was replaced.The second catheter then had the same problem.Only the use of a third catheter could solve the problems.The procedure was successfully completed without any consequences for the patient.Surgery was delayed 30 minutes.Additional information was received.No difficulty experienced while maneuvering the catheter or during the withdrawal.Unknown if the catheter pebax or if any other part of the tip was physically damaged.Clarification received was that there were 4 qdot micro catheters with this same issue.The biosense webster, inc.Product analysis lab received the two devices for evaluation and per the evaluation completions on 29-feb-2024, revealed reddish brown material inside and a hole on the pebax with internal parts exposed on both devices.This event was originally considered non-reportable, however, bwi became aware of the hole on the pebax with internal parts exposed on both devices on 29-feb-2024 and have assessed these returned conditions as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 08-feb-2024.The device evaluation was completed on 29-feb-2024.The device was returned for evaluation.The returned device's visual inspection and screening test were performed following biosense webster (bwi) procedures.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 after the procedure but, it cannot be conclusively determined.The force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The force issue reported by the customer could not be replicated, however, the reddish material on the pebax could be related to the force issue.Therefore, the complaint was confirmed.It should be noted that product failure is multifactorial.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00889 for product code d139402 (qdot micro) (2) mfr for product code d139402 (qdot micro).

• 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: 18925371
• MDR Text Key: 337921306
• Report Number: 2029046-2024-00890
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017076
• UDI-Public: 10846835017076
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139402
• Device Lot Number: 31155567L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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: OSCOR DESTINO REACH 8,5F SHEATH; QDOT MICRO, UNI, TC, F; QDOT MICRO, UNI, TC, F; QDOT MICRO, UNI, TC, F; UNK_NGEN RF GENERATOR