BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 6788268 · Received August 11, 2017

    Report

    Report Number
    2024168-2017-06600
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    July 13, 2017
    Report Date
    September 15, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ESTIMATED DATE OF EVENT. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: DATE OF EVENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FOOT BREAK AND PATIENT EFFECTS; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THERE IS NO PRODUCT QUALITY ISSUE IDENTIFIED WITH THIS DEVICE BASED ON THE INFORMATION REVIEWED. SUS VOLUNTARY EVENT REPORT MW 5071349.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN A CALCIFIED COMMON FEMORAL ARTERY WAS PERFORMED USING TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PERFORMED AT ANOTHER HOSPITAL. REPORTEDLY, THE TAVR WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITHOUT ISSUE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. APPROXIMATELY A DAY OR TWO POST PROCEDURE, THE PATIENT'S "LEFT" WENT COLD. A FOOT OF THE PROGLIDE DEVICE WAS FOUND IN THE VESSEL CAUSING AN OCCLUSION. A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED FOOT. THE PATIENT WAS FINE POST SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: SUS VOLUNTARY EVENT REPORT MW 5071349: DURING THE TIME OF THE PERCLOSE DEPLOYMENT, A PIECE OF THE FOOT PLATE FRACTURED AND WAS RETAINED INSIDE THE VESSEL. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569242 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7051042

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEPARIN