BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1960044 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00271
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE CLIP WAS NOT FIRED. DURING TESTING, THE DEVICE WAS CLEANED AND RE-ASSEMBLED FOR RE-DEPLOYMENT AND THE RESULTS WERE SUCCESSFUL AS DESIGNED. THE THUMB ADVANCER STROKE WAS COMPLETED WITHOUT ANY OBSERVABLE RESISTANCE THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTY ADVANCING THE THUMB ADVANCER. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS PARTIALLY DEPLOYED AS IT LOST ITS ARTERIAL ACCESS DURING THE THUMB ADVANCER STROKE. THE PROBABLE ROOT CAUSE FOR THE DEVICE LOOSING ACCESS IS RELATED TO THE OPERATIONAL CONTEXT AS THE DEVICE WAS INADVERTENTLY PULLED OUT OF THE ANATOMY WHILE ADVANCING THE THUMB ADVANCER. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    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 LARGE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS DIFFICULTY ADVANCING THE THUMB ADVANCER TO SPLIT THE SHEATH. THE PHYSICIAN RETRACTED THE DEVICE FOR POSITION AGAINST THE VESSEL WALL AND LOST VESSEL ACCESS WITH THE LOCATOR WINGS OPEN. WHAT APPEARED TO BE A "PIECE OF TISSUE" WAS SEEN ON THE END OF THE DEVICE. IT WAS REPORTED THAT THE ARTERY WAS A LARGE ARTERY. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 920196H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention HEPARIN