BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2132502 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04291
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. INCORRECT REMOVAL (VESSEL LOCATOR WINGS WERE NOT COLLAPSED BY USING THE SAFETY RELEASE BUTTON). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE DIFFICULT TO REMOVE COULD NOT BE DETERMINED. REPORTEDLY, THE DEVICE SAFETY RELEASE SYSTEM WAS NOT USED TO HELP REMOVE THE DEVICE. PER THE INSTRUCTIONS FOR USE, IF RESISTANCE IS MET UPON REMOVAL OF THE DEVICE, COLLAPSE THE VESSEL LOCATOR WINGS USING THE ACCESS PORTS AND THE SAFETY RELEASE BUTTON. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF AN ISSUE WITH THE QUALITY OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE SE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE. ALTHOUGH A NICK AND SPREAD WAS PERFORMED TO HELP RELEASE THE DEVICE, THE DEVICE SAFETY RELEASE SYSTEM WAS NOT USED TO CLOSE THE VESSEL LOCATOR WINGS. THE DEVICE WAS PULLED FROM THE ANATOMY. THE CLIP DID NOT ACHIEVE HEMOSTASIS AND MANUAL COMPRESSION WAS APPLIED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THE ACCESS SITE WAS DESCRIBED AS HAVING A LOT OF ADIPOSE TISSUE. 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