MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Failure to Sense (1559)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that there was magnetic interference during ablation.The generator was switched, did not solve it.Ablation cable was switched, did not solve it.Indifferent electrode was switched, did not solve it.Catheter cable was switched, did not solve it.New catheter fixed it.The procedure was prolonged for 10 minutes due to the reported issue.There was no patient consequence.The customer¿s reported magnetic sensor error is not considered to be mdr reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2023, visual inspection was performed and a reddish material and a hole were observed in the pebax component.These findings were reviewed and determined the issue of a hole in the pebax was assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and magnetic sensor functionality 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.Magnetic sensor functionality test was performed and the device was recognized and visualized on the system; however, high force values were observed on the screen.The issue 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 magnetic/force issue reported by the customer was 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 17024590
• MDR Text Key: 317173960
• Report Number: 2029046-2023-01172
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031
• 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: 05/30/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30892361L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/30/2023
• Date Device Manufactured: 09/08/2022
• 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: THMCL SMTCH SF BID, TC, D-F; UNKNOWN ABLATION CABLE; UNKNOWN CATHETER CABLE; UNKNOWN GENERATOR; UNKNOWN INDIFFERENT ELECTRODE