BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH CATHETER

    MDR report key: 16288225 · Received February 2, 2023

    Report

    Report Number
    2029046-2023-00214
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 15-FEB-2023, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH CATHETER. IT WAS REPORTED THAT ABLATION SPRING BROKE DURING PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. DEVICE EVALUATION DETAILS: VISUAL INSPECTION WAS PERFORMED AND REDDISH MATERIAL AND A HOLE WERE OBSERVED IN THE PEBAX COMPONENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30897748L] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH CATHETER. IT WAS REPORTED THAT ABLATION SPRING BROKE DURING PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. CRACKED/BROKEN PEBAX IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690023 THERMOCOOL SMARTTOUCH CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30897748L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown