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

Catalog Number D134722IL

Device Problems Signal Artifact/Noise (1036); Break (1069); Failure to Sense (1559)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical and magnetic sensor functionality tests of the returned device were performed in accordance with bwi procedures.Visual analysis revealed that the shaft was bent, the dome was squashed, electrode #4 was lifted, and the peek housing was broken and the internal components were exposed.A magnetic sensor functionality test was performed, and the device was recognized correctly; however, errors 80 (invalid force measurements) and sh (a force related error) were observed, and electrodes #3 and #4 were displayed black on the screen.An electrical test was performed, and two open circuits were found on the tip area.The open circuits on electrodes #3 and #4 could be related to alert 80 and error sh observed during this investigation and could be related to the described event.The conditions of the shaft, dome and peek housing may be related to the handling of the device outside the manufacturing facilities; however, this could not be conclusively determined.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 31137594l, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendation: ecg (electrocardiogram) 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.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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post procedure the bwi product analysis lab identified that the shaft was bent, the dome was squashed, electrode #4 was lifted, and the peek housing was broken and the internal components were exposed.During the procedure itself, there was a magnetic sensor error displayed (error code 105).A second device was used to complete the operation.There was no adverse event reported on patient.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 18479286
• MDR Text Key: 332988433
• Report Number: 2029046-2024-00116
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134722IL
• Device Lot Number: 31137594L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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