BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3071055 · Received April 22, 2013

    Report

    Report Number
    2024168-2013-02476
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 29, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. IT WAS REPORTED THAT A VENOUS SHEATH WAS NEXT TO THE ARTERIAL SHEATH. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS A VENOUS SHEATH NEXT TO THE FEMORAL SHEATH DURING THE CLOSURE PROCEDURE. 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
    172454 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30207J1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6F HEPARIN