BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4863934 · Received June 23, 2015

    Report

    Report Number
    2024168-2015-03536
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 10, 2015
    Report Date
    September 3, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED FAILURE TO DEPLOY WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE REPORTED FAILURE TO DEPLOY AND TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MFR REFERENCE NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR AORTIC REPAIR (EVAR). REPORTEDLY, THE SUTURES FAILED TO DEPLOY. TWO ADDITIONAL PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. THE ARTERIOTOMY WAS A 6FR AND DURING THE EVAR PROCEDURE THE SHEATH WAS UPSIZED TO AN 8FR THEN A 14FR. THE EVAR PROCEDURE WAS COMPLETED AND A SURGICAL CUT DOWN WAS DONE TO SUTURE THE VESSEL CLOSED AND ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404611 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 50302K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention