BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 6948640 · Received October 13, 2017

    Report

    Report Number
    1035166-2017-00087
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    October 12, 2017
    Report Date
    March 8, 2018
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    UDI-DI
    00813502011562
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS. THIS INITIAL MDR IS BEING SUBMITTED TO MEET OUR REQUIREMENTS OF REPORTING. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE CLINICAL TEAM DID NOT ATTRIBUTE THE DEATH TO THE DEVICE. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY AND NO NEW FAILURE MODE IDENTIFIED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. QUALITY ASSURANCE PROCEDURE (ABIOMED INTRODUCER SHEATH) IN-PROCESS & FINAL INSPECTION: DEVICE IS TESTED ONE HUNDRED PERCENT FOR CAP AND SEAL INSPECTION, A LEAK TEST IS PERFORM ACCORDING TO PROCEDURE, ALSO AN OCCLUSION TEST IS PERFORM. SIDEPORT WITH VALVE ASSEMBLY SAMPLES ARE RANDOMLY SELECTED FOR VISUAL INSPECTION: WITH THE NAKED EYE, INSPECT SIDEPORT ASSEMBLY FOR EXCESSIVE GLUE. SMEARED GLUE TO THE SIDEPORT ASSEMBLY IS NOT ACCEPTABLE. VERIFY THE SIDEPORT TUBE IS PROPERLY BONDED TO HUB AND STOPCOCK VALVE BY GENTLY TUGGING ON BOTH JOINTS. NOTE: IF ONE PART FAILS, ONE HUNDRED PERCENT INSPECTION OF THE LOT FOR BOND INTEGRITY OF SIDEPORT TUBE TO HUB AND STOPCOCK VALVE IS REQUIRED. INSTRUCTIONS FOR USE (IFU), ABIOMED ADELANTE S2 - HEMOSLATICP PEEL AWAY & SIDEPORT. UNDER PRECAUTION: ASPIRATION AND SALINE FLUSHING OF THE SHEATH, DILATOR, AND VALVE SHOULD BE PERFORMED TO HELP MINIMIZE THE POTENTIAL FOR AIR EMBOLISM AND CLOT FORMATION. ASPIRATE ALL AIR FROM THE SHEATH VALVE ASSEMBLY BY USING A SYRINGE CONNECTED TO THE SIDEPORT. FLUSH THE SHEATH WITH 5 CC OF SALINE IMMEDIATELY BEFORE PEELING THE SHEATH AWAY IN ORDER TO MINIMIZE BACK BLEEDING.

    Description of Event or Problem · 1

    CASE INFORMATION: (B)(6) YEAR OLD MALE WITH STEMI BROUGHT TO THE HOSPITAL. FEMORAL ANGIOGRAM PERFORMED PRIOR TO SHEATH INSERTION SHOWING SUFFICIENT VESSEL SIZE. THE 14 FR OSCOR INTRODUCER SHEATH WAS INSERTED IN THE RFA. ILIAC DISSECTION WAS NOTED POST SHEATH INSERTION WITH ANGIOGRAM. IMPELLA INSERTION WAS ABORTED. THE PATIENT DID NOT SURVIVE. THE SHEATH WAS TAKEN AWAY WITH PATIENT AND COULD NOT BE RETRIEVED. WE WILL NOT BE RECEIVING THIS PRODUCT BACK, SO THIS WILL BE ALL THE INFORMATION WE WILL BE GETTING REGARDING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728523 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC 0052-3014 C1-13369 00813502011562

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death