BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1902113 · Received November 10, 2010

    Report

    Report Number
    2953144-2010-02792
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLUNGER AND NEEDLES, THE COMPLETE SUTURE, POSTERIOR NEEDLE TIP, ANTERIOR AND POSTERIOR CUFFS AND LINK MATERIAL WERE NOT RETURNED WHICH LIMITED THE INVESTIGATION. EVALUATION OF THE RETURNED DEVICE COMPONENTS FOUND NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE TUBE, GUIDE, FOOT OR SHEATH. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING THE POSTERIOR CUFF HAD BEEN EJECTED FROM THE POSTERIOR FOOT. INSPECTION OF THE FOOT ASSEMBLY DID NOT DETECT ANY DAMAGE TO INDICATE A POSSIBLE CUFF MISS OR NEEDLE STRIKE OR POSSIBLE MALFUNCTION OF THE DEVICE. DURING TESTING, A PROXY PLUNGER/NEEDLE ASSEMBLY WAS INSERTED TO TEST FOR NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. A POSSIBLE CAUSE FOR THE REPORTED CUFF MISS MAY HAVE BEEN NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE PROGLIDE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS) WAS INFLATED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE BALLOON OUTSIDE THE ANATOMY. THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION 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 - VASCULAR SOLUTIONS NA 920356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN