BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1934901 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03308
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND ONLY AN INITIAL SLIT ON THE EXCHANGE SHEATH. THE CUTTER WAS UNDAMAGED INDICATING THE HUB OF THE EXCHANGE SHEATH HAD STUCK THE CUTTER. THE DISTAL END OF THE EXCHANGE SHEATH WAS DAMAGED FROM STRIKING THE OPENED LOCATOR WINGS DUE TO STRETCHING DURING THUMB ADVANCER AND CLIP DELIVERY TUBESET DEPLOYMENT. THE EXCHANGE SHEATH WAS REMOVED REVEALING THAT THE LOCATOR WINGS REMAINED DEPLOYED AND BENT. ALTHOUGH IT WAS REPORTED THAT AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED AND WHEN THE DEVICE WAS REMOVED, THE STARCLOSE SE CLIP WAS FOUND CAUGHT UP IN THE EXCHANGE SHEATH, THE INVESTIGATION REVEALED HE EXCHANGE SHEATH WAS NOT FULLY ENGAGED TO THE CLIP APPLIER. ADDITIONALLY, INTERNAL EXAMINATION FOUND THE CATCH REMAINED IN A PRE-DEPLOYED POSITION AND THE CLIP REMAINED LOADED ON THE CARRIER TUBE. AFTER THE DEVICE WAS REASSEMBLED, AN ATTEMPT TO LOAD THE EXCHANGE SHEATH ON TO THE CLIP APPLIER WAS SUCCESSFUL. AN AUDIBLE CLICK WAS HEARD AS EXPECTED AND THE EXCHANGE SHEATH HUB WAS SECURELY CONNECTED TO THE CLIP APPLIER. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THIS COMPLAINT WAS DUE TO INCORRECT TECHNIQUE DURING DEVICE DEPLOYMENT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    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 THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. WHEN THE DEVICE WAS REMOVED, THE STARCLOSE SE CLIP WAS FOUND "CAUGHT UP" IN THE EXCHANGE SHEATH. 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-REDWOOD CITY 910426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention