BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1913214 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03066
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HUB OF THE EXCHANGE SHEATH WAS DETACHED FROM THE DEVICE AND NOT THE SHEATH DETACHED FROM THE HUB AS REPORTED. THE HUB OF THE EXCHANGE SHEATH WAS INSPECTED AND THERE WAS NO WITNESS MARK ON THE END CAP TO SUGGEST THAT THE HUB WAS SECURELY ENGAGED WITH THE DEVICE. SUBSEQUENTLY, WHEN DEPRESSING THE PLUNGER TO DEPLOY THE LOCATOR WINGS AND INITIATE THUMB ADVANCER AND DELIVERY TUBESET ADVANCEMENT, THE HUB WAS SEPARATED FROM THE DEVICE AS OBSERVED. DURING TESTING, THE DEVICE WAS RE-ASSEMBLED FOR RE-DEPLOYMENT ATTEMPT AND THE RESULT WAS SUCCESSFUL. THE HUB OF THE EXCHANGE SHEATH REMAINED SECURELY ENGAGED WITH THE DEVICE THROUGHOUT THE DEPLOYMENT SEQUENCE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR HUB DETACHING FROM THE DEVICE IS INCORRECT INSTALLATION TECHNIQUE. NO MANUFACTURING OR QUALITY ISSUES WERE 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE MAJ-855 AUXILIARY WATER TUBE WAS USED BY THE USER FACILITY AS A CONNECTOR BETWEEN A SCICAN INNOVA E3 AUTOMATIC ENDOSCOPE REPROCESSOR (AER) AND THE AUXILIARY WATER CHANNEL OF OLYMPUS 180 SERIES GASTROSCOPES. OLYMPUS WAS ALSO INFORMED THAT WHEN THE MAJ-855 WAS USED IN THIS CONFIGURATION, THE AER DOES NOT GENERATE SUFFICIENT PRESSURE TO RELIABLY FORCE DISINFECTANT THROUGH THE ONE-WAY VALVE OF THE MAJ-855 INTO THE ENDOSCOPE. THERE WERE NO REPORTS OF ANY INFECTIONS ASSOCIATED WITH THIS REPORT.

    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 RIGHT COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHILE DEPLOYING THE THUMB ADVANCER THE EXCHANGE SHEATH DISCONNECTED FROM THE HUB. IT WAS THOUGHT THAT THE SHEATH AND HUB HAD NOT BEEN COMPLETELY CONNECTED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 920346H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention