BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131969 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04280
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE REPORTED MISSING KNOT COULD NOT BE DETERMINED. HOWEVER, THE OFF-LABEL USE OF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PER THE INSTRUCTIONS FOR USE, THE DEVICE IS INDICATED FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE. 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. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID REVEAL ANY NONCONFORMING MATERIAL RECORDS RELATED TO THE EVENT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL VEIN AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE RAIL SUTURE WAS PULLED TO ADVANCE THE KNOT, THE KNOT WAS NOT THERE. THE DEVICE WAS REWIRED AND ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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-TEMECULA-CT 030386H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ANGIOMAX