BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1842218 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01935
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    November 9, 2008
    Report Date
    November 10, 2008
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY. EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE CLIP WAS FULLY DEPLOYED AND THE ACCESS PORTS HAD BEEN UTILIZED TO FACILITATE DEVICE REMOVAL. BENT LOCATOR WINGS WERE ALSO FOUND. ALL OF THE LOCATOR WINGS WERE INTACT AND SECURE WITHIN THE VESSEL LOCATOR ASSEMBLY. BENT LOCATOR WINGS ARE CONSISTENT WITH DIFFICULT TO REMOVE DEVICE. THE MOST PROBABLE ROOT CAUSE FOR THE WING'S CONDITION MAY HAVE BEEN THE COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DEPLOYED LOCATOR WINGS AND THE DISTAL END OF THE DEVICE'S CLIP DELIVERY TUBE DURING THE DISTAL DEPLOYMENT OF THE THUMB ADVANCER BENDING THE WINGS DISTALLY. THIS CONDITION CAN RESULT IN THE INABILITY OF THE LOCATOR WINGS TO RETRACT INTO THE CLIP DELIVERY TUBE AFTER CLIP DEPLOYMENT. NO MANUFACTURING OR QUALITY INSPECTION ISSUES WERE DETECTED. 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 TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. AN ATTEMPT WAS MADE TO RELEASE THE DEVICE USING THE ACCESS PORTS BUT THIS WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED BY USING BOTH COUNTER-TRACTION AND AN ASSERTIVE PULL. MANUAL COMPRESSION WAS APPLIED FOR LESS THAN 5 MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. NO ADDITIONAL INFORMATION 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 69079-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention