BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1211088 · Received October 24, 2008

    Report

    Report Number
    2953144-2008-01722
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOODY CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERFICIAL FEMORAL ARTERY (SFA) BELOW THE BIFURCATION). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE BREAK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA) BELOW THE BIFURCATION. REPORTEDLY, INSTEAD OF HEARING A "CLICK" AN UNUSUAL SNAP WAS HEARD WHEN DEPLOYING THE NEEDLES (STEP 2). WHEN THE NEEDLES WERE DISENGAGED BY PULLING THE PLUNGER ASSEMBLY BACK RESISTANCE WAS FELT AND THE RAIL SUTURE BROKE AND REMAINED IN THE PT'S ARTERY. AN ATTEMPT TO ACHIEVE IMMEDIATE HEMOSTASIS WAS MADE USING AN ANGIOSEAL; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. THE PT WAS TAKEN TO SURGERY AND BOTH THE SUTURE AND ANGIOSEAL WERE REMOVED. THE ARTERY WAS PATCHED TO ACHIEVE HEMOSTASIS. REPORTEDLY, THE FOOT PLATE HAD CAUGHT ON THE POSTERIOR WALL AT THE JUNCTION OF THE SFA AND PROFUNDA CAUSING THE NEEDLES TO GO THROUGH BOTH WALLS AND CAUSED THE SUTURE TO SNAP. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. 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 REDWOODY CITY NA 67125-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OTHER: HEPARIN| SHEATH: 6FR| GUIDE CATH: 5FR| GUIDE WIRE: 0.035