BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1970684 · Received January 25, 2011

    Report

    Report Number
    2024168-2011-00456
    Event Type
    Injury
    Date Received
    January 25, 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
    PA, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ADDITIONALLY, 26 UNOPENED STERILE PROGLIDE DEVICES, FROM THE SAME LOT NUMBER, WERE RETURNED FROM THE CUSTOMER FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). TWENTY SIX UNUSED REPRESENTATIVE SAMPLES WITH THE SAME PART AND LOT NUMBER AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON 13 OF THE RETURNED DEVICES AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES. 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 AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE FRACTURED INSIDE THE ARTERY WHERE THE FOOT AND SHEATH COME TOGETHER. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE BROKEN PIECE OF THE DEVICE AND CLOSE THE ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THE PHYSICIAN FELT THAT SCAR TISSUE IN THE TARGET GROIN CONTRIBUTED TO THE DEVICE BREAKAGE. THOUGH REQUESTED, 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 950146H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 6F SHEATH