BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 5220194 · Received November 12, 2015

    Report

    Report Number
    2024168-2015-06806
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 12, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE OTHER THREE PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MFR REFERENCE NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. NO FEMORAL ANGIOGRAM WAS TAKEN. REPORTEDLY, A CUFF MISS OCCURRED. THREE ADDITIONAL PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749601 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention