BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851660 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02304
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 17, 2009
    Report Date
    August 19, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER HAD BEEN RETRACTED PROXIMALLY AFTER CLIP DEPLOYMENT. BECAUSE THE VESSEL LOCATOR WINGS AUTOMATICALLY COLLAPSE DURING CLIP DEPLOYMENT THIS FINDING INDICATES THE PLUNGER AT SOME POINT WAS RE-ACTIVATED AFTER THE THUMB ADVANCER HAD BEEN RETRACTED. THE VESSEL LOCATOR WINGS WERE BROKEN AT THE DISTAL RETAINING RING BUT REMAINED ATTACHED TO THE DEVICE AT THE PROXIMAL RETAINING RING AND PUSHER BODY BOND. THE REPORTED ACCESS SITE BEING IN A HEAVILY SCARRED COMMON FEMORAL ARTERY MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE REPORTED EXPERIENCE. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE ROOT CAUSE OF THE BENT AND BROKEN VESSEL LOCATOR WINGS AND SUBSEQUENT DIFFICULT REMOVAL IS RELATED TO OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MFG OR QUALITY 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 ACHIEVED ARTERIOTOMY CLOSURE OF A HEAVILY SCARRED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WERE NO REPORTED ADVERSE PATIENT 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 79010-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention