BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1934916 · Received December 21, 2010

    Report

    Report Number
    2953144-2010-03313
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ALTHOUGH IT WAS REPORTED THAT THE DEVICE WAS PARTIALLY DEPLOYED, EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS FULLY CLIP DEPLOYED AND THE EXCHANGE SHEATH WAS FULLY SLIT AND UNDAMAGED. ALL EXTERNAL AND INTERNAL OBSERVATIONS OF THE DEVICE WERE NORMAL FOR A FULLY CLIP DEPLOYED DEVICE. THE FLEX-GUIDE DID NOT EXHIBIT ANY DAMAGE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MAY HAVE BEEN MANIPULATED POST PROCEDURE, BUT THAT COULD NOT BE CONFIRMED. THE DEVICE WAS RESET FOR LAB REDEPLOYMENT TESTING RESULTING IN SUCCESSFUL DEPLOYMENT WITH COMPLETE UNRESTRICTED THUMB ADVANCER/DELIVERY TUBE DEPLOYMENT. RESISTANCE ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT IS CONSISTENT WITH RADIAL FORCE CONSTRICTION ON THE EXCHANGE SHEATH. FACTORS THAT MAY CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS, NEITHER CONDITION OF WHICH COULD BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE DIFFICULTY ENCOUNTERED DURING DEPLOYMENT COULD NOT BE DETERMINED. 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, DURING THUMB ADVANCER DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED AND EXCHANGE SHEATH SPLITTING COULD NOT BE COMPLETED. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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 930406H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention