BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1973123 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00521
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND BOTH CUFFS INSIDE THE FOOT POCKETS, THE SUTURE KNOT WAS UNRAVELED, THE LINK WAS SLACK, AND THE NEEDLE PLUNGER WAS OUTSIDE THE DEVICE. THE DEVICE INDICATED THAT THE NEEDLE PLUNGER WAS RETRACTED PRIOR TO DEPLOYING THE NEEDLES. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE ANTERIOR CUFF SUCCESSFULLY CAPTURED THE NEEDLE DURING PLUNGER REINSERTION. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE WAS PARTIALLY DEPLOYED DUE TO AN INCORRECT DEPLOYMENT TECHNIQUE. 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 RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE FOOT WAS DEPLOYED, THE PLUNGER WAS BACKED OUT. THE PLUNGER WAS PUSHED BACK IN TO COMPLETE REMAINING STEPS; HOWEVER, WHEN THE PLUNGER WAS PULLED OUT THE NEEDLES PRESENTED WITHOUT THE SUTURES OR LINKS ATTACHED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 AV-TEMECULA-CT 940016H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention