BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1022113 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00195
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION FINDINGS, BOTH CUFFS WERE ENGAGED TO THEIR RESPECTIVE NEEDLE TIPS. THE LINK WAS STILL ATTACHED TO ANTERIOR CUFF AND WAS PULLED FROM THE POSTERIOR CUFF. THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. WE WERE NOT ABLE TO ESTABLISH A ROOT CAUSE BASED ON THE INVESTIGATION FINDINGS. NO MFG ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. THE DEVICE #1: PERCLOSE PROGLIDE, PART #12673-03, LOT# 60121-6H IS BEING FILED UNDER MEDWATCH MDR# 2953144-2008-00193. THE DEVICE #2: PERCLOSE PROGLIDE, PART# 12673-03, LOT# 60130-6H IS BEING FILED UNDER MEDWATCH MFR#2953144-2008-00194.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #3 CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE NEEDLE PLUNGER OUT, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND A SECOND AND THIRD PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    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 60130-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LOT# 60121-6H| DEVICE #1 PERCLOSE PROGLIDE PART# 12673-03| DEVICE 2# PERCLOSE PROGLIDE PART# 12673-03| LOT# 60130-6H