BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1851647 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02263
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 11, 2007
    Report Date
    July 14, 2007
    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
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED DEVICE FOUND BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. THERE WAS ONLY ABOUT 3/8" OF MONOFILAMENT STILL ATTACHED TO THE NEEDLE TIP. THE REST OF THE MONOFILAMENT WAS NOT RETURNED WITH THE DEVICE. THE KNOT PUSHER SUTURE TRIMMER WAS NOT RETURNED. THERE WAS NO ABNORMAL OBSERVATION FOUND. BASED ON THE INVESTIGATION, A KNOT LOCK OCCURRED AND GOT STUCK INSIDE THE TISSUE TRACT. HOWEVER, THE DEVICE CONFORMED TO SPECIFICATION, BECAUSE THERE WERE NO ABNORMAL OBSERVATIONS WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND RESPECTIVE NEEDLE TIPS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE KNOT LOCK COULD NOT BE DETERMINED. NO MALFUNCTION WAS DETECTED.

    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 FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE KNOT WITH THE SUTURE TRIMMER TO THE ARTERIOTOMY, THE KNOT LOCKED AND BECAME STUCK INSIDE THE TISSUE TRACT. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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-VASCULAR SOLUTIONS NA 44166-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention OTHER: HEPARIN