BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER STEERABLE DELIVERY SHEATH

    MDR report key: 17149498 · Received June 18, 2023

    Report

    Report Number
    2135147-2023-02635
    Event Type
    Malfunction
    Date Received
    June 18, 2023
    Date of Event
    November 7, 2022
    Report Date
    June 18, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    05415067036025
    PMA / PMN Number
    K212026
    Removal / Correction Number
    2135147-6/8/23-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF ST ELEVATION WAS REPORTED. A RETURNED DEVICE INSPECTION, TO RULE OUT ANY DEVICE-RELATED CAUSES, 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 . ALTHOUGH NO AIR EMBOLUS WAS OBSERVED, IT IS IMPORTANT TO NOTE THAT ABBOTT HAS IDENTIFIED AIR EMBOLISM AS A POTENTIAL ILLNESS OR INJURY. CUSTOMERS HAVE REPORTED AIR EMBOLI HAVING RESULTED IN TRANSIENT ST SEGMENT ELEVATION RESOLVING SPONTANEOUSLY AND, LESS COMMONLY, HEMODYNAMIC INSTABILITY REQUIRING MEDICAL INTERVENTION. THE CAPA (ACTION 132620) INVESTIGATION HAS CONFIRMED THAT THE ASDS INTEGRATED HEMOSTASIS VALVE DESIGN AND PROCEDURAL USE ALLOW FOR AIR TO INGRESS WHEN OPTIMAL AIR MANAGEMENT TECHNIQUES ARE NOT ADHERED TO BY PHYSICIANS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION TO MONITOR THIS ISSUE.NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ATTACHED TO THE SIDE PORT OF THE DELIVERY SHEATH. WHEN THE DELIVERY SHEATH WAS INTRODUCED TO THE PATIENT AND AFTER THE GUIDEWIRE WAS REMOVED, THE PATIENT NOTED TO HAVE ST SEGMENT ELEVATION. THERE WAS NO EXCESSIVE RESISTANCE OR DIFFICULTY NOTICED WHEN THE DELIVERY SYSTEM WAS INTRODUCED TO THE PATIENT. THE ST ELEVATION RESOLVED WITHOUT INTERVENTION AFTER A FEW MINUTES, AND THE PROCEDURE WAS CONTINUED. NO AIR EMBOLUS WAS OBSERVED IN THE PATIENT. ST ELEVATION WAS NOTED AGAIN AFTER THE AMULET OCCLUDER WAS INSERTED THROUGH THE DELIVERY SHEATH. THERE WAS NO EXCESSIVE RESISTANCE OR DIFFICULTY NOTICED WHEN THE DEVICE WAS PASSED THROUGH THE DELIVERY SHEATH. NO ASPIRATION WAS DONE ON THE DELIVERY SHEATH. THE PATIENT'S VITAL SIGNS WERE STABLE, AND THE ST ELEVATIONS RESOLVED AGAIN WITHOUT INTERVENTION. THE AMULET OCCLUDER WAS IMPLANTED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE AND DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057941 AMPLATZER STEERABLE DELIVERY SHEATH CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL ASDS-14F-075 8448549 05415067036025

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female AMULET LAA OCCLUDER, 9-ACP2-007-022, 8559617.