BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1904797 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02890
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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.THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLUNGER/NEEDLES ASSEMBLY, ANTERIOR CUFF, AND LINK MATERIAL WERE NOT RETURNED. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE SUTURE WAS RETURNED COMPLETE, FREE OF THE DEVICE AND UNDAMAGED WITH THE POSTERIOR NEEDLE TIP ATTACHED. THE POSTERIOR NEEDLE TIP WAS ENGAGED WITH THE POSTERIOR CUFF, WHICH HAD BEEN EJECTED FROM THE POSTERIOR FOOT, EVIDENCED BY THE BLOW THROUGH MARKS ON THE POSTERIOR FOOT. THERE WAS NO DETECTED HANDLE, GUIDE TUBE, GUIDE, FOOT, OR SHEATH DAMAGE. THE POSTERIOR CUFF WAS EXAMINED AND THE LINK HAD BROKEN FROM THE POSTERIOR CUFF LEAVING A SMALL SEGMENT WITHIN THE CUFF. A PROXY PLUNGER/NEEDLE ASSEMBLY WAS USED TO TEST THE NEEDLE TRAJECTORY. THE TEST WAS SUCCESSFUL WITH BOTH NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET. INTERNAL INSPECTION OF THE RETURNED DEVICE COMPONENTS FOUND NO DETECTED OBSERVATIONS INDICATING ANY POSSIBLE RESTRICTION TO DEPLOYMENT OF THE SUTURE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE LINK TO CUFF DETACHMENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "BROACHING FOR HIPSTAR STEM AND ADAPTER BROKE. USED A BACKUP ADAPTER AND IT BROKE. FINISHED SURGERY WITH HAND IMPACTOR BROACH HANDLE. NO DELAYS, NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 920286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention