BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1970718 · Received January 25, 2011

    Report

    Report Number
    2024168-2011-00461
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. USE OF THE DEVICE IN A CALCIFIED LESION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A 6 F GUIDE CATHETER, PT2 BIOTRINIK GUIDE WIRE, MDT SPRINTER DILATATION CATHETER.

    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 A CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE COULD NOT BE REMOVED FROM THE PATIENT ANATOMY. THE SAFETY RELEASE MECHANISM AND ACCESS PORTS AS WELL AS COUNTER TRACTION WERE USED UNSUCCESSFULLY. X-RAY OF THE VESSEL FOUND PLAQUE ENTRAPPED BETWEEN THE VESSEL WALL AND THE LOCATOR WINGS, WHICH PREVENTED THE CLIP FROM CLOSING THE PUNCTURE SIDE AND THE LOCATOR WINGS FROM COLLAPSING. DURING TRANSPORT OF THE PATIENT TO THE OPERATION ROOM THE PLAQUE MOVED SLIGHTLY AND THE DEVICE SLIPPED OUT OF THE VESSEL. THE SURGEON CLOSED THE PUNCTURE SITE WITH A SINGLE STITCH. THERE WERE NO ADVERSE PATIENT SEQUELAE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention