BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3851454 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03599
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE NEEDLE TO CUFF MISS WAS CONFIRMED. ANALYSIS OF THE RETURNED DEVICE FOUND A CUFF TAB DETACHMENT. CUFF TABS MEASURE ONE ON-HUNDREDTH (0.01) OF AN INCH SQUARE AND DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. ALTHOUGH, THE BROKEN CUFF TAB WAS NOT RETURNED, NO ADVERSE PATIENT HEALTH IMPACT HAS BEEN REPORTED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULT. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329000 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31126K1

    Patients

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