BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4942947 · Received July 27, 2015

    Report

    Report Number
    2024168-2015-04181
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 16, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A CONCLUSIVE CAUSE OF THE REPORTED SUTURE CAPTURING THE BACK WALL OF THE ARTERY COULD NOT BE DETERMINED. 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 A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC PROCEDURE ON (B)(6) 2015. REPORTEDLY, THE PATIENT RETURNED WITH UNSPECIFIED SYMPTOMS. IT WAS FOUND THAT THE PROGLIDE SUTURE HAD CAPTURED THE BACK WALL OF THE ARTERY. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. BALLOON ANGIOPLASTY WAS PERFORMED TO RE-OPEN THE RIGHT COMMON FEMORAL ARTERY, VIA LEFT COMMON FEMORAL ARTERY ACCESS. THE PATIENT WAS REPORTED TO BE DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486585 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R