BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1953094 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00107
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE WHOLE MONOFILAMENT WAS RETURNED LOOSE. BOTH CUFFS WERE STILL ATTACHED TO THE LINK AND THE POSTERIOR CUFF WAS ENGAGED TO THE POSTERIOR NEEDLE TIP. THE ANTERIOR CUFF TAB WAS DAMAGED. BASED ON THE INVESTIGATION FINDINGS, THE ANTERIOR CUFF DETACHED FROM THE ANTERIOR NEEDLE TIP DURING PLUNGER REMOVAL. THE CUFF DETACHMENT FROM THE NEEDLE TIP IS LIKELY THE RESULT OF RESISTANCE OR DRAG ENCOUNTERED DURING THE PROCEDURE. THERE WAS NO ABNORMAL OBSERVATION FOUND ON THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS EVENT. THEREFORE, THE ROOT CAUSE FOR THE ANTERIOR CUFF TO NEEDLE TIP DETACHMENT IS UNDETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. 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. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    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, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. 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 940286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention