BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1930625 · Received December 16, 2010

    Report

    Report Number
    2953144-2010-03256
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT BOTH CUFFS WERE ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. THERE WAS APPROXIMATELY 1 INCH OF MONOFILAMENT STILL ATTACHED TO THE NEEDLE TIP AND THE REST OF THE MONOFILAMENT WAS NOT RETURNED. THE CONDITION OF THE DEVICE INDICATES A SUCCESSFUL DEPLOYMENT. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED ON THE SKIN SURFACE AND NOT ON THE ARTERY BY AN OPERATOR THAT WAS NOT TRAINED IN THE USE OF THE DEVICE. THIS IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU STATES THAT THE DEVICE SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND THERAPEUTIC INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORDS 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. (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD (OPERATOR NOT TRAINED, FAILURE TO FOLLOW STEPS/INSTRUCTIONS) 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 RESIDENT, NOT TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS POSITIONED IN THE PATIENT, THE MARKER LUMEN WAS ACTIVATED, BUT NOT STABILIZED AND THE DEVICE WAS NOT IN THE ARTERY DURING DEPLOYMENT. SUBSEQUENTLY, THE SUTURES WERE DEPLOYED ON THE SKIN SURFACE AND AROUND THE DEVICE. THE SUTURES WERE CUT TO RELEASE THE DEVICE AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 920126H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5 FR SHEATH