BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THMCL SMTCH SF BID, TC, D-F

    MDR report key: 15671688 · Received October 26, 2022

    Report

    Report Number
    2029046-2022-02640
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 21-SEP-2022. THE DEVICE EVALUATION WAS COMPLETED ON 28-SEP-2022. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE CONDUCTED. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE DEVICE. MAGNETIC SENSOR FUNCTIONALITY TEST WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND NO FORCE ISSUES WERE DETECTED DURING THE ANALYSIS. HOWEVER, THE HOLE IN THE PEBAX WITH REDDISH MATERIAL INSIDE IT COULD BE RELATED TO THE MAGNETIC SENSOR ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30818408L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. REGARDING TO THE PEBAX DAMAGE, THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING INFORMATION: TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED A HOLE IN THE PEBAX INITIALLY, IT WAS REPORTED THAT THE MAPPING CATHETER ICON WAS STEADY UNTIL ABLATION WAS STARTED. THE CATHETER ICON APPEARED TO SHAKE. THE GROUNDING CABLE WAS THEN REPLACED, AND THE ISSUE DID NOT RESOLVE. THE CATHETER CABLE WAS REPLACED, AND THE ISSUE DID NOT RESOLVE. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE ICON JUMPING ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. CATHETER ICON JUMPING IS A HIGHLY DETECTABLE ISSUE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND A HOLE IN THE PEBAX AND REDDISH MATERIAL INSIDE IT. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 28-SEP-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480898 THMCL SMTCH SF BID, TC, D-F CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30818408L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BRAND CABLE| UNK BRAND CATHETER