BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2872293 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07894
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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 BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. IT WAS REPORTED THE BOTH COMMON FEMORAL ARTERIES WERE MILDLY CALCIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUFF MISSES OCCURRED DURING ATTEMPTED SUTURE PLACEMENT IN BOTH COMMON FEMORAL ARTERIES USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE VESSELS WERE MILDLY CALCIFIED. AT THE RIGHT COMMON FEMORAL ARTERY A CUFF MISSES OCCURRED WITH TWO PROGLIDE DEVICES. TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED USING THE PRECLOSE TECHNIQUE. AT THE LEFT COMMON FEMORAL ARTERY TWO PROGLIDE DEVICES WERE DEPLOYED USING THE PRECLOSE TECHNIQUE, A CUFF MISS OCCURRED WITH ONE PROGLIDE DEVICE. AN ADDITIONAL PROGLIDE DEVICE WAS SUCCESSFULLY DEPLOYED USING THE PRECLOSE TECHNIQUE. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE SUCCESSFULLY DEPLOYED DEVICES. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20928J1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SHEATH: 7F, 14F, 16F HEPARIN