BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE 45X45 DELIVERY SHEATH

    MDR report key: 16727388 · Received April 12, 2023

    Report

    Report Number
    2135147-2023-01594
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 21, 2023
    Report Date
    June 7, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K163000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF RESISTANCE WHILE ADVANCING THE DEVICE THROUGH THE DELIVERY SYSTEM AND DELIVERY SHEATH BEING KINKED WAS REPORTED. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION AND FOUND KINKS THROUGHOUT SHEATH. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 12F AMPLATZER AMULET DELIVERY SHEATH (LOT 7826835) WAS CHOSEN FOR PROCEDURE. THE PATIENT'S ACCESS WAS VERY CALCIFIED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WAS DIFFICULTY WHEN THE SHEATH WAS INTRODUCED INTO THE PATIENT AND WHILE ADVANCING THE DEVICE THOUGH THE PATIENT. IT WAS DISCOVERED DURING ADVANCEMENT THAT THE DELIVERY SYSTEM HAD A HOLE IN IT AND WAS ALSO KINKED. THE DELIVERY SHEATH LOOKED ATYPICAL AND WAS REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER 12F AMPLATZER AMULET DELIVERY SHEATH (LOT 7826835), AND AN ATTEMPT WAS MADE TO IMPLANT A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT 7822491), BUT IT WAS UNABLE TO BE POSITIONED IN THE CORRECT LOCATION IN THE LEFT ATRIAL APPENDAGE. THE DEVICES WERE REPLACED WITH A 14F AMPLATZER AMULET DELIVERY SHEATH (LOT 8476935) AND ANOTHER 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT 7633347), BUT IT WAS ALSO UNABLE TO BE IMPLANTED DUE TO POSITIONING. NO DEVICE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242930 AMPLATZER TORQVUE 45X45 DELIVERY SHEATH CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL 7826835

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown