BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6102626 · Received November 15, 2016

    Report

    Report Number
    2024168-2016-07964
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 15, 2016
    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
    FL, 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 ANALYSIS. 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 THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER TWO PERCLOSE PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH THREE PROGLIDE DEVICES WERE ATTEMPTED IN A COMMON FEMORAL ARTERY (CFA) USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, AN UNKNOWN DEVICE FAILURE OCCURRED WITH ALL THREE PROGLIDE DEVICES. ADDITIONAL PROGLIDE DEVICES WERE USED FOR SUCCESSFUL SUTURE PLACEMENT USING THE PRECLOSE TECHNIQUE. THE TAVR PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES FROM THE PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755034 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention