MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

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 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-may-2023.The investigation was completed on 10-jul-2023.Further images received showed reddish material in the pebax of the device.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, screening test, and temperature and impedance test of the returned device were performed following bwi procedures.Visual inspection was performed and reddish material and a hole were observed in the pebax component.The force feature was tested on the carto and high force values were observed in addition, no temperature and impedance values were observed, these issues could be related to the reddish material inside the pebax component.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The reported issues by the customer were confirmed.The root cause of the hole on the pebax cannot be determined, it should be noted that the damage 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially it was reported that the catheter showed discrepancy in the force reading.At times indicating that it was colliding with another catheter but in reality only the ablation catheter was in the heart.The error connector was changed and the error persisted.The catheter was changed and it resolved the issue.When observing the catheter, it could be seen that there was blood in the force sensor system.It is important to mention that the catheter was always irrigated.The procedure was not delayed.The procedure was completed successfully.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The force issue was assessed as not 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 blood in the force sensor system issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 10-jul-2023 there was reddish material and a hole observed in the pebax component.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 10-jul-2023.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17470843
• MDR Text Key: 321514737
• Report Number: 2029046-2023-01708
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• 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: 08/07/2023

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: D133602
• Device Lot Number: 30779720M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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: UNKNOWN BRAND CATHETER
• Patient Sex: Male