BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3884888 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03950
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BECAUSE THE SUTURE WAS NOT RETURNED, THE REPORTED SUTURE BREAK COULD NOT BE CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A SEARCH OF LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES ASSOCIATED WITH THIS LOT. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION REVIEWED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT PLACEMENT OF THE PROGLIDE DEVICE SUTURE WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ANGIOPLASTY IN THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL. THE ARTERIOTOMY WAS A 6F AND REMAINED A 6F SHEATH DURING THE INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360057 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40118K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, HEPARIN