BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 5577409 · Received April 14, 2016

    Report

    Report Number
    2024168-2016-02403
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 21, 2016
    Report Date
    May 4, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED NEEDLE TO CUFF MISS COULD NOT BE CONFIRMED AS ALL COMPONENTS WERE NOT RETURNED FOR ANALYSIS. A CONCLUSIVE CAUSE FOR THE REPORTED NEEDLE TO CUFF MISS/SUTURE RETRIEVAL ISSUE COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO PROCEDURAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. EIGHT UNUSED, STERILE PROGLIDE DEVICES WERE RETURNED FOR EVALUATION, TWO WITH LOT # 5121741 AND FIVE WITH LOT # 50909K2. VISUAL AND FUNCTIONAL TESTING WAS SUCCESSFULLY PERFORMED WITH NO MALFUNCTION NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER SIX PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING PROGLIDE DEVICES WITH A 6F SHEATH AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, CUFF MISSES OCCURRED WITH SEVEN PROGLIDE DEVICES. AN EIGHTH PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233730 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 5121741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention