BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMULET STEERABLE DELIVERY SHEATH

    MDR report key: 19741534 · Received July 15, 2024

    Report

    Report Number
    2135147-2024-03411
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 20, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K232690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. H6: 2017 - IMPROPER OR INCORRECT PROCEDURE OR METHOD, RETRACTED WITHIN DELIVERY SYSTEM.

    Additional Manufacturer Narrative · 0

    AN EVENT OF LARGE AIR EMBOLUS DURING MANEUVERING OF DELIVERY SHEATH IN THE PATIENT WAS REPORTED. THE PATIENT LOST ARTERIAL PRESSURE AND PULSE. VENTRICULAR TACHYCARDIA, ST ELEVATION, AND HYPOTENSION WERE NOTED; CODE BLUE WAS CALLED, COMPRESSIONS WERE INITIATED AND EPINEPHRINE ADMINISTERED. RESTORATION OF CIRCULATION WAS OBTAINED. FOLLOWING REMOVAL OF THE RIGHT GROIN SHEATH, DEEP VEIN THROMBOSIS WAS OBSERVED AND HEPARIN WAS ADMINISTERED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER OBSERVATION AND TREATMENT. INFORMATION FROM FIELD INDICATED THAT THE 31 MM AMULET OCCLUDER WAS NOT IMPLANTED AFTER TWO ATTEMPTS DUE TO INCOMPATIBLE ANATOMY AND A REPLACEMENT 28 MM AMULET OCCLUDER WAS THEN ATTEMPTED UTILIZING THE SAME DELIVERY SHEATH. PLEASE NOTE THAT PER INSTRUCTIONS FOR USE, "IF THE DEVICE IS RETRACTED WHILE IT IS IN THE SHEATH, THE DEVICE AND THE SHEATH MUST BOTH BE REMOVED AND REPLACED. FAILURE TO REPLACE BOTH THE DEVICE AND THE SHEATH MAY RESULT IN SHEATH AND/OR DEVICE MALFUNCTION." A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET SPECIFICATIONS. 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

    (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8894755) WAS CHOSEN FOR IMPLANTATION UTILIZING A 14F AMULET STEERABLE DELIVERY SHEATH (LOT: 10097388). THE OCCLUDER WAS NOT IMPLANTED AFTER TWO ATTEMPTS DUE TO INCOMPATIBLE ANATOMY. A REPLACEMENT 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS THEN ATTEMPTED UTILIZING THE SAME DELIVERY SHEATH. DURING MANEUVERING IN THE PATIENT, A LARGE AIR EMBOLUS WAS NOTED IN THE DELIVERY SHEATH. THE PATIENT LOST ARTERIAL PRESSURE AND PULSE. VENTRICULAR TACHYCARDIA, ST ELEVATION, AND HYPOTENSION NOTED. CODE BLUE WAS CALLED AND COMPRESSIONS WERE INITIATED AND EPINEPHRINE ADMINISTERED. RESTORATION OF CIRCULATION WAS OBTAINED. FOLLOWING REMOVAL OF THE RIGHT GROIN SHEATH, DEEP VEIN THROMBOSIS WAS OBSERVED AND HEPARIN WAS ADMINISTERED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER OBSERVATION AND TREATMENT. THE PATIENT WAS PLACED ON VENTILATOR. THE PATIENT WAS REPORTED TO BE NEUROLOGICALLY INTACT - ABLE TO FOLLOW COMMANDS AND RESPOND TO VERBAL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268881 AMULET STEERABLE DELIVERY SHEATH CATHETER DELIVERY SHEATH DQY ABBOTT MEDICAL 10097388

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R 28MM AMPLATZER AMULET OCCLUDER, 9-ACP2-010-028 (LO