BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842265 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01945
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    August 11, 2009
    Report Date
    August 11, 2009
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVAL OF THE RETURNED DEVICE REVEALED THE EXCHANGE SHEATH WAS STRETCHED AND TORN BY THE CLIP TINES. ONE OF THE LOCATOR WINGS WAS BROKEN BUT REMAINED SECURE WITHIN THE LOCATOR. A POSSIBLE CAUSE FOR THE EXCHANGE SHEATH STRETCHING MAY INCLUDE AN INADEQUATE BLUNT DISSECTION OF THE ACCESS SITE. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED, CREATING RESISTANCE TO THE THUMB ADVANCER DEPLOYMENT AS REPORTED. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT BECAUSE THE CLIP TINES WILL PUNCTURE THE DISTAL END OF THE SHEATH AS OBSERVED. ADDITIONALLY, TISSUE COMPACTION CAN BEND THE LOCATOR WINGS AND EVENTUALLY BREAK THEM DURING THE REMOVAL OF THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE STRETCHED EXCHANGE SHEATH AND BROKEN LOCATOR WINGS IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MFG OR QUALITY ISSUES WERE DETECTED. 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

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALTHOUGH RESISTANCE WAS MET, THUMB ADVANCER DEPLOYMENT WAS COMPLETED. AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED FOR 4 TO 5 MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 77041-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention