BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2141719 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04505
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INITIALLY REPORTED THE DEVICE WAS AVAILABLE FOR RETURN AND EVALUATION; SUBSEQUENTLY, IT WAS REPORTED THAT THE DEVICE WAS DISCARDED OR MISPLACED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITHOUT THE PRODUCT TO EXAMINE AND A SPECIFIC DEVICE FAILURE REPORTED, AN ANALYSIS COULD NOT BE PERFORMED AND A DETERMINATION OF A CAUSE OR PROBABLE CAUSE COULD NOT BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A PROGLIDE DEVICE WAS ATTEMPTED AND AN UNSPECIFIED FAILURE OCCURRED. ANOTHER PROGLIDE WAS ATTEMPTED, ALSO WITH AN UNSPECIFIED FAILURE OCCURRING. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention