BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1823430 · Received August 24, 2010

    Report

    Report Number
    2953144-2010-01700
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INDICATION FOR USE. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "EVENT DESC: A VASCULAR CLOSURE DEVICE WAS NEEDED FOR THE RIGHT FEMORAL ARTERY PUNCTURE SIGHT. UPON DEPLOYMENT OF THE CLOSURE DEVICE, THE DEVICE COULD NOT BE REMOVED FROM THE PUNCTURE SIGHT. PATIENT TRANSFERRED TO THE OPERATING ROOM FOR REMOVAL."

    Description of Event or Problem · 1

    DEVICE ISSUE: NEEDLE-TO-CUFF MISS, RETRACTION ISSUE-FOOT, DETACHED DISTAL SHEATH. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FOREIGN BODY REMOVAL, SURGICAL REPAIR/HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. HOWEVER, A FEMORAL ANGIOGRAM WAS NOT PERFORMED AND THE DEVICE WAS FOUND TO BE DEPLOYED IN THE RIGHT PROFUNDA ARTERY. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. DURING DEVICE REMOVAL, THE FOOT COULD NOT BE RETRACTED. THE PATIENT WAS BROUGHT TO SURGERY WHERE AN ATTEMPT WAS MADE TO REMOVE THE DEVICE BY PULLING IT OUT, BUT CAUSED THE DISTAL GUIDE TO DETACH. IT WAS DECIDED TO DISMANTLE THE DEVICE AFTER IT WAS NOTICED THAT THE DEVICE HAD BEEN FOUND TO BE DEPLOYED IN THE RIGHT PROFUNDA ARTERY WITH A PORTION THE FOOT DEPLOYED THROUGH THE ARTERY. AFTER REMOVING ALL PARTS OF THE DEVICE, THE VESSEL WAS SURGICALLY REPAIRED. HOSPITALIZATION WAS PROLONGED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 90033-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R