BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1951264 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00061
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE SUTURE, LINK, POSTERIOR NEEDLE TIP, AND BOTH CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION REVEALED A DAMAGED ANTERIOR NEEDLE BARB. THIS INDICATED THAT THE ANTERIOR NEEDLE WAS INITIALLY ENGAGED WITH THE ANTERIOR CUFF DURING NEEDLE DEPLOYMENT. HOWEVER, WHEN RETRACTING THE NEEDLE PLUNGER, THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT OCCURRED. DURING TESTING, THE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE THAT COULD CONTRIBUTE TO THE CUFF-TO-NEEDLE TIP DETACHMENT. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. 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 FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING SUTURE RETRIEVAL, THE SUTURE CAME OFF WHEN THE PLUNGER WAS PULLED BACK. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 AV-TEMECULA-CT 890226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN