MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139501

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a qdot-micro, bi-directional, d-d curve, c3, split handle catheter.About an hour after the vessel puncture, when attempting to ablate the right pulmonary vein gap, ablation stopped due to a rapid temperature rise when attempting to ablate.This occurred four times in a row after the first ablation.The physician withdrawn the catheter out of the patient¿s body and checked the tip of the catheter and confirmed that there was a pool of blood in the film of the second and third electrodes.The bwi representative then examined the tip of the third electrode in detail and found a small indentation, from which blood entered the second and third electrode and it was thought that the sudden temperature increase may have occurred as the ablation started.The ngen generator dd not allow ablation beyond the cut-off value 47 or 200o impedance.The issue was resolved by replacing the qdot micro catheter with another new one.Abbott agilis m curve 8.5fr sheath was used.The procedure was completed without any other problems or patient's consequence.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).The device was returned to biosense webster (bwi) for evaluation.A visual inspection, patency, temperature and impedance test of the returned device were performed following bwi procedures.Visual inspection was performed a hole on the surface with reddish material inside the pebax was observed.The temperature and impedance test was 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 hole on the surface could be related with the manipulation of the device during the procedure, however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The issues reported by the customer were confirmed, the foreign material inside the pebax could be the root cause of the high temperature reported by the customer.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.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.This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.¿ manufacturer's ref.No: (b)(4).

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, D-D CURVE, C3, SPLIT HANDLE
• 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: 17623639
• MDR Text Key: 322814492
• Report Number: 2029046-2023-01894
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: 10846835016710
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139501
• Device Lot Number: 30911537L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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: ABBOTT AGILIS M CURVE 8.5FR SHEATH; UNK_NGEN RF GENERATOR