BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1001800 · Received February 19, 2008

    Report

    Report Number
    2953144-2008-00080
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 25, 2008
    Manufacturer
    ABBOTT VASCULAR -VASCULAR SOLUTIONS - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS FULLY CLIP-DEPLOYED. THE EXCHANGE SHEATH WAS ELONGATED AND DAMAGED HAD CAPTURED THE DEPLOYED CLIP IN ITS DISTAL END, WHICH INTERFERED WITH THE PROPER COLLAPSE OF THE VESSEL LOCATOR WINGS CAUSING THEM TO BEND. ADDITIONALLY, THE GARAGE TUBE LEAVES WERE NOTED TO BE SLIGHTLY "BOWED". THESE FINDINGS ARE CONSISTENT WHEN AN UNKNOWN RESISTANCE IS APPLIED TO THE EXTERNAL AREAS OF THE EXCHANGE TUBE AND THE DELIVERY TUBE DURING THE DELIVERY TUBE DISTAL DEPLOYMENT PROCESS. NO ADDITIONAL DAMAGE OF THE DEVICE WAS DETECTED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CLIP MISLOCATION. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER DELIVERING THE CLIP IT WAS NOTICED THAT THE CLIP DEPLOYED ON THE DISTAL END OF THE EXCHANGE SHEATH. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED OF ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR -VASCULAR SOLUTIONS - REDWOOD CITY NA 59204-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK