BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1892717 · Received November 3, 2010

    Report

    Report Number
    2953144-2010-02699
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ABBOTT VASCULAR-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE, BOTH CUFFS WERE STILL ATTACHED TO THE LINK, AND THE POSTERIOR CUFF WAS ENGAGED TO POSTERIOR NEEDLE TIP. THE ANTERIOR CUFF TABS WERE DAMAGED. TWO OF THE ANTERIOR CUFF TABS WERE BROKEN OFF AND WERE NOT RETURNED WITH THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE ANTERIOR CUFF DETACHED FROM THE ANTERIOR NEEDLE TIP DURING REMOVAL OF THE PLUNGER. THE CUFF DETACHMENT FROM THE NEEDLE TIP IS LIKELY THE RESULT OF RESISTANCE OR DRAG ENCOUNTERED DURING THE PROCEDURE. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE RETURNED DEVICE THAT THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE ROOT CAUSE FOR THE ANTERIOR CUFF TO NEEDLE TIP DETACHMENT IS UNDETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, IT WAS REPORTED THAT THE VENTRICULAR SETSCREW ON THIS DEVICE WOULD NOT HOLD THE LEAD; UNABLE TO DEPLOY. THEREFORE, THE PACEMAKER WAS NOT IMPLANTED.

    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, THE "NEEDLES DIDN'T TAKE" AND A CUFF MISS MAY HAVE OCCURRED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, 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 SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR-REDWOOD CITY NA 920436H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention