BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1914145 · Received December 3, 2010

    Report

    Report Number
    2953144-2010-03077
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURE OF THE DEVICE. THE PROBABLE CAUSE FOR THE CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS 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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE.SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.

    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 930376H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention