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

Catalog Number D139505

Device Problem Insufficient Cooling (1130)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, no temperature issues were observed on the generator screen.The customer complaint was not confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature and impedance test, and patency test of the returned device were performed following bwi procedures.Visual analysis revealed a hole in the pebax area with reddish material inside.The temperature and impedance test were 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 foreign material inside the pebax could be related to the reported event.As such, the high temperature issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device 31043567l, and no internal actions related to the reported complaint condition were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of ¿appropriate term/code not available¿ and h 6.Investigation conclusions code of ¿no problem detected (d14) ¿ represent the photo/video analysis.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 cardiac ablation 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 "qmode plus lesions would not be delivered", though about 10 lesions had already been delivered along the l posterior wall.The temperature on the ngen generator was 35-37 degrees prior to ablation.The temperature exceeded the max cut off at 55.The physician checked the position, tried a new position (sup/roof left ridge), reset the eco dongle, reconnected the cable, and there was no resolution.The qdot catheter was replaced with a new thermocool® smart touch® sf catheter.The case was completed with no harm to the patient.The high temperature cut-off exceeded issue was assessed as non mdr reportable.Since generator stopped delivering rf, the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-dec-2023, there was a hole in the pebax with reddish material inside the hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 18-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: 18518935
• MDR Text Key: 332993583
• Report Number: 2029046-2024-00174
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/16/2024

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: 31043567L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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: EXTENSION CABLE; NGEN RF GENERATOR; RF GEN TO CARTO FOCAL CABLE; UNK_SMART TOUCH BIDIRECTIONAL SF