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

Catalog Number D139505

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter address line 1 (cont.): (b)(6).The device was returned to biosense webster for evaluation.Visual inspection and functionality test of the returned device were performed following bwi procedures.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The root cause of the damage on the pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.An electrical, magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No electrical, force, or magnetic issues were observed.The reported issues could be related to the foreign material inside the pebax.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 batch number 31064729l, and no internal actions were identified.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation 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 a noisy signal was observed on the ep recording system (ge).This signal was fine on carto.They changed the ablation catheter cable but it did not solve the problem.The physician decided to continue the procedure.When the physician performed the few first radiofrequency application, they observed a rise in contact force (above 80g).The physician was not pushing the catheter toward the atrium wall.They decided to change the ablation catheter and the problem was resolved.No adverse patient consequence was reported.The force issue, as well as the signal noise, 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 07-dec-2023, there was a hole in the pebax and foreign reddish material was inside of it.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 07-dec-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: 18445187
• MDR Text Key: 331912421
• Report Number: 2029046-2024-00052
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

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: 31064729L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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: UNK BRAND CABLE.; UNK BRAND CABLE.