BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851772 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02226
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 15, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND THE CLIP WAS FULLY DEPLOYED. THE THUMB ADVANCER HAD BEEN RETRACTED APPROXIMATELY 6 CM DISTAL OF THE FINISH WINDOW OF STEP #3. THIS FINDING CONFIRMS THE REPORT OF USING THE ACCESS PORTS TO UNLOCK THE THUMB ADVANCER AND RETRACTING IT PROXIMALLY. THE PLUNGER WAS IN THE DISTAL ACTIVATED POSITION WITH THE #2 VISIBLE IN THE WINDOW AND SAFETY RELEASE BUTTON WAS ALSO ENGAGED WITH THE RETAINING RING. BASED ON THE RETRACTION OF THE THUMB ADVANCER AFTER CLIP DEPLOYMENT, THE PLUNGER HAD BEEN RE-ENGAGED AFTER THE PROCEDURE. THE VESSEL LOCATORS WERE IN THE OPENED POSITIONS. ONE SIDE OF THE RIBBON WAS BROKEN AT THE DISTAL RETAINING RING, BUT WAS STILL ATTACHED AT THE PROXIMAL RETAINING RING AND PUSHER BODY BONDS. ALL COMPONENTS OF THE LOCATOR WINGS WERE RETURNED. DURING TESTING, THE SAFETY RELEASE BUTTON WAS ACTIVATED RELEASING THE PLUNGER TO COLLAPSE THE VESSEL LOCATOR WING WITHOUT DIFFICULTY. AT CLIP DEPLOYMENT, THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE AND NOT INTERFERE WITH CLIP DELIVERY. BASED ON THE INVESTIGATIONAL FINDINGS, THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS COMPACTION OF SUBCUTANEOUS TISSUE BETWEEN THE DISTAL END OF THE TUBE SET AND THE LOCATOR WINGS DURING THUMB ADVANCER DEPLOYMENT. THIS MAY CREATE DISTAL FORCES RESULTING IN BENDING AND BREAKAGE OF THE LOCATOR WINGS AND SUBSEQUENT DIFFICULTY WITH DEVICE REMOVAL. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. A REVIEW OF THE HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE FROM THE PT'S ANATOMY. THE CLIP DELIVERED AND ACHIEVED HEMOSTASIS APPROPRIATELY. 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 83009-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention