BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2991173 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01289
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4): FEMORAL ANGIOGRAM WAS NOT TAKEN. PER THE INSTRUCTIONS FOR USE - PERFORM A FEMORAL ANGIOGRAM TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF A CUFF MISS WAS UNABLE TO BE CONFIRMED BECAUSE KEY COMPONENTS OF THE DEVICE WERE NOT RETURNED. 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. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT TAKEN. THE PROGLIDE INSTRUCTIONS FOR USE STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE NEEDLE MISSED THE FOOT PLATE, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO FEMORAL ANGIOGRAM WAS TAKEN PRIOR TO THE PROCEDURE. 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
    95787 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21026J1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SHEATH: 6F, ANGIOMAX