BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3781247 · Received April 30, 2014

    Report

    Report Number
    2024168-2014-02696
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE THREE OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. BECAUSE THE PLUNGER, SUTURE, LINK, NEEDLES AND CUFFS WERE NOT RETURNED WITH THE DEVICE, THE SCOPE OF THIS INVESTIGATION WAS LIMITED AND THE REPORTED CUFF MISS COULD NOT BE CONFIRMED. BASED ON A VISUAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF BOTH COMMON FEMORAL ARTERIES WAS ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATHS PRIOR TO CORE VALVE PROCEDURE. BOTH COMMON FEMORAL ARTERIES WERE MODERATELY CALCIFIED AT THE ACCESS SITES. REPORTEDLY, AT THE RIGHT COMMON FEMORAL ARTERY A SUTURE BREAK OCCURRED. REPORTEDLY, AT THE LEFT COMMON FEMORAL ARTERY 3 PROGLIDE DEVICES HAD CUFF MISSES. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY PLACED USING THE PRE-CLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 14F AND THE CORE VALVE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED ON THE RIGHT BY APPLYING MANUAL ARTERIAL COMPRESSION. HEMOSTASIS WAS ACHIEVED ON THE LEFT USING THE SUCCESSFULLY PRE-PLACED SUTURES OF THE TWO ADDITIONAL PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND AND THE LARGE HOLE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259312 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40213K1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SHEATH: 6F, 14F, HEPARIN