BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7311789 · Received March 2, 2018

    Report

    Report Number
    2024168-2018-01555
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    January 2, 2018
    Report Date
    March 2, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 WAS NOT RETURNED FOR EVALUATION. 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 REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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. THE OTHER TWO PROGLIDE DEVICES REFERENCED, ARE FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    RECEIVED USER FACILITY MEDWATCH REPORT # (B)(4) STATING: EVENT DESCRIPTION: "3 PROGLIDE 6F PERCLOSE SUTURE MEDIATED CLOSURE SYSTEM#12673-03 WITH LOT NUMBERS 7110942 EXP DATE 09-30-2019 DID NOT DEPLOY. TWO OTHER PROGLIDES NEEDED TO BE OPENED IN ORDER TO COMPLETE THE PROCEDURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : TEVAR, ILIAC STENT PLACEMENT. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G.BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154905 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7110942 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention