BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3841323 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03476
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BECAUSE THE PART OF THE SUTURE CONTAINING THE KNOT WAS NOT RETURNED, IT COULD NOT BE DETERMINED IF THE KNOT WAS SUCCESSFULLY ADVANCED TO THE PUNCTURE SITE TO CLOSE THE VESSEL. THEREFORE, THE REPORTED FAILURE TO CLOSE THE VESSEL AFTER SUCCESSFULLY DEPLOYING THE DEVICE COULD NOT BE CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NONCONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INVESTIGATION, 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 YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN IMPELLA PROCEDURE, THE SUTURES OF TWO PROGLIDE DEVICES WERE PLACED IN PRECLOSE TECHNIQUE IN THE LEFT COMMON FEMORAL ARTERY USING A 6F SHEATH. THE SHEATH WAS UPSIZED TO 8F FOR THE IMPELLA PROCEDURE. AFTER THE PROCEDURE THE KNOTS OF TWO SUCCESSFULLY PREPLACED PROGLIDE DEVICES WERE ADVANCED AND TIGHTENED WITH NO ISSUE; HOWEVER, THE ACCESS SITE CONTINUED TO BLEED. A THIRD PROGLIDE DEVICE WAS USED, BUT HEMOSTASIS WAS NOT ACHIEVED. THE SUTURES OF THE THREE PROGLIDE DEVICES WERE REMOVED AND A 14F SHEATH WAS PLACED IN THE ACCESS SITE TO STOP THE BLEEDING AND A PERFORATION OF THE ARTERY OCCURRED. HEMOSTASIS WAS ACHIEVED WITH SURGICAL INTERVENTION. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE DEPLOYMENT TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318752 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20928J2

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 6F, 8F, 14F, HEPARIN