BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851823 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02249
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 8, 2010
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE DEVICE WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCE HAD BEEN RETRACED AS FAR PROXIMAL AS POSSIBLE. THE EXTERNAL AND INTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYMENT AND RETRACTED POSITION AND UNDAMAGED WITH THE EXCEPTION OF THE VESSEL LOCATOR WINGS. THE VESSEL LOCATOR WINGS WERE BROKEN AT THE DISTAL RETRAINING RING BUT STILL ATTACHED TO THE DEVICE AT THE PROXIMAL RETAINING RING AND PUSHER BODY BOND. ALL OF THE VESSEL LOCATOR COMPONENTS WERE RETURNED. THERE WAS NO OTHER DAMAGE OR ABNORMALITIES DETECTED. THE BROKEN VESSEL LOCATOR WINGS ARE CONSISTENT WITH A DIFFICULT TO REMOVE DEVICE. THE UNLOCKED AND RETRACTED THUMB ADVANCER IS ALSO CONSISTENT WITH THE STEPS IN THE IFU AND TRAINING GUIDE FOR RESISTANCE MET UPON REMOVAL. THEREFORE THE REPORTED EXPERIENCED IS CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE BROKEN LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT THROUGH THE TISSUE TRACT WHICH MAY CREATE DISTAL FORCES RESULTING IN BREAKAGE OF THE LOCATOR WINGS AND SUBSEQUENTLY CONTRIBUTING TO DIFFICULT DEVICE REMOVAL. NO MFG OR QUALITY INSPECTION 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 TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. A "LITTLE FORCE" WAS REPORTEDLY APPLIED TO REMOVE THE DEVICE. THE CLIP FROM THE STARCLOSE SE DEVICE ACHIEVED HEMOSTASIS. NO ADVERSE PT EFFECTS WERE REPORTED. 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-VASCULAR SOLUTIONS NA 84031-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention