BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1902111 · Received November 10, 2010

    Report

    Report Number
    2953144-2010-02795
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 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 Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CUFFS REMAINED IN THE POCKETS, THE LINK WAS LOOSE, THE POSTERIOR NEEDLE WAS EJECTED FROM THE NEEDLE SHANK BUT WAS NOT ENGAGED WITH THE CUFF, AND THE SUTURE KNOT WAS UNRAVELED. THIS IS INDICATIVE OF RETRACTING THE NEEDLE PLUNGER PRIOR TO DEPLOYING THE NEEDLES. DURING LAB TESTING, WE REMOVED THE NEEDLE PLUNGER FROM THE DEVICE AND FOUND BOTH NEEDLES WERE BENT AT THE PROXIMAL END, CONSISTENT WITH CLOSING THE LEVER TO PARK THE FOOT PRIOR TO COMPLETELY RETRACTING THE NEEDLE PLUNGER. A PROXY PLUNGER WAS INSERTED INTO THE DEVICE TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. DURING THE PROXY PLUNGER INSERTION, THE ANTERIOR CUFF SUCCESSFULLY CAPTURED THE NEEDLE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE PARTIALLY DEPLOYED DEVICE IS INCORRECT TECHNIQUE BECAUSE THE DEVICE DEPLOYMENT SEQUENCE IN THE INSTRUCTION FOR USE (IFU) WAS NOT FOLLOWED. THE NEEDLE PLUNGER WAS PARTIALLY RETRACTED PRIOR TO BEING DEPRESSED TO DEPLOY THE NEEDLES. ALSO, THE LEVER WAS CLOSED TO PARK THE FOOT TO REMOVE THE DEVICE PRIOR TO COMPLETELY REMOVING THE NEEDLE PLUNGER FROM THE DEVICE, RESULTING IN BENT NEEDLES AT THE PROXIMAL END AS OBSERVED. NO MANUFACTURING OR QUALITY ISSUE DETECTED. A 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. IT WAS FELT THE CUFF MISS WAS DUE TO PLAQUE. HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    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 890386H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention