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

Catalog Number D139505

Device Problem Signal Artifact/Noise (1036)

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

Event Date 10/05/2023

Event Type  malfunction  

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 on the pebax.Initially, it was reported that there was noise on the "dot" observed on the catheter viewer.They replaced the dongle, cable, and the catheter without resolution.They rebooted the ngen system and the issue did not resolve.The catheter was replaced a second time and the issue was resolved.No adverse patient consequence was reported.The signal noise issue was 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 04-dec-2023, there was a hole on the pebax section and reddish material was found inside the pebax.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 04-dec-2023.

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.Visual inspection and electrical tests of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax.Due to the reddish material inside the pebax, the device was inspected under a microscope and a hole was found on the pebax section.An electrical test was performed, and no electrical issues were found.The damage on the pebax surface could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.Although electrical issue reported by the customer could not be replicated during the product investigation; the damage observed on the pebax could be related to the issue reported by the customer.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint 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).

• 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: 18419803
• MDR Text Key: 331705488
• Report Number: 2029046-2023-03125
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: 31073336L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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: QDOT MICRO, BI, TC, D-F.; QDOT MICRO, BI, TC, D-F.; UNK BRAND CABLE.; UNK BRAND DONGLE.; UNK_NGEN RF GENERATOR.