BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1172105 · Received September 23, 2008

    Report

    Report Number
    2953144-2008-01546
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO INSERT EXCHANGE SHEATH. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, IT WAS DIFFICULT TO ATTACH THE CLIP APPLIER TO THE EXCHANGE SHEATH. THE SHEATH SPLITTER WAS BENT OUTWARD AND DID NOT ALLOW THE TWO TO ENGAGE. AN ATTEMPT WAS MADE TO BEND IT BACK, BUT IT WOULD NOT ENGAGE WITH THE EXCHANGE SHEATH. THE GUIDE WIRE WAS REINSERTED AND A SECOND STARCLOSE SE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 66057-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention