BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1851804 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02345
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT IN THE PRE-DEPLOYED POSITION. DRIED BLOOD WAS OBSERVED ON THE DEVICE, SUGGESTING THAT IT MIGHT HAVE BEEN INTRODUCED INTO THE BODY. DURING TESTING, THE GUIDE WIRE WAS INSERTED FROM BOTH ENDS OF THE SHEATH WITHOUT DIFFICULTY. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION AND A ROOT CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDING RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, BEFORE THE DEVICE ENTERED THE PATIENT ANATOMY, IT COULD NOT BE ADVANCED OVER THE GUIDE WIRE. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. 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-VASCULAR SOLUTIONS NA 90015-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention