BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1171309 · Received September 22, 2008

    Report

    Report Number
    2953144-2008-01521
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 28, 2008
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DISTAL GUIDE DETACHED. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: SURGICAL RETRIEVAL. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT DURING REMOVAL OF THE DEVICE FROM PATIENT'S ANATOMY AND THE DISTAL GUIDE DETACHED. THE DISTAL GUIDE WAS SURGICALLY REMOVED, AND THE ARTERY WAS SURGICALLY REPAIRED WITH A FEMORAL PATCH. THE PT WAS REPORTEDLY MORBIDLY OBESE WITH A DEEP TISSUE TRACT. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO 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 67120-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention