BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1912576 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03059
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. (B)(4). DEVICES #1 AND #3 - PROGLIDE (PART #12673-03; LOT #930076H) ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION OF THE RETURNED DEVICE REVEALED A NEEDLE STRIKE MARK AT THE POSTERIOR FOOT. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS DESIGNED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF DURING NEEDLE DEPLOYMENT IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY ISSUE WAS 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 THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED DEVICE FAILURE OCCURRED. THE DEVICE WAS REMOVED AND TWO ADDITIONAL PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. THE METHOD OF HOW HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT HAD ONLY ONE PROGRAM TO WORK WITH BUT THAT THE NEUROSTIMULATOR GAVE HER GOOD RESULTS. SHE WAS GIVEN 4 NEW PROGRAMS EVEN THOUGH THE DEVICE WAS HELPING WITH HER SYMPTOMS. SUBSEQUENT INFO RECEIVED INDICATED THAT THE PT EXPERIENCED A SHOCKING SENSATION AND HAD PROBLEMS WITH HER DEVICE SYSTEM. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1&#3:PROGLIDE (PART#12673-03,LOT #930076H)