BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7311784 · Received March 2, 2018

    Report

    Report Number
    2024168-2018-01553
    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). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE. 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. (B)(4).

    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
    154903 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