BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE 45X45 DELIVERY SHEATH

    MDR report key: 19020667 · Received April 2, 2024

    Report

    Report Number
    2135147-2024-01478
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 8, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    05415067028037
    PMA / PMN Number
    K163000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF TIP OF THE DELIVERY SYSTEM BEING DAMAGED WAS REPORTED. ONE IMAGE FROM FIELD APPEARED TO SHOW A DILATOR PASSED THROUGH THE TIP OF SHEATH. THE TIP OF SHEATH APPEARED DEFORMED AND DAMAGED. THERE APPEARED BLOOD LIKE SUBSTANCE PRESENT ON THE SHEATH. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 12F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN TO IMPLANT A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER. WHILE INSERTING THE SHEATH INTO THE PATIENT GROIN OVER THE NON-ABBOTT GUIDEWIRE, THE TIP OF THE DELIVERY SYSTEM SHEATH WAS DAMAGED. A REPLACEMENT AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9212535) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY AND THE PATIENT WAS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866544 AMPLATZER TORQVUE 45X45 DELIVERY SHEATH CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL 9212535 05415067028037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLU