BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2864021 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07794
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF SUTURE BREAKAGE DURING PLUNGER RETRACTION WAS NOT CONFIRMED. IT WAS OBSERVED THAT A LINK PULL OCCURRED AT THE POSTERIOR CUFF WHICH WOULD APPEAR SIMILAR TO THE REPORTED CUFF MISS. 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 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 SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH THE PROGLIDE DEVICE IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM REPAIR. THE ARTERIOTOMY WAS 6 FR AND THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED. REPORTEDLY, DURING PLUNGER RETRACTION THE SUTURE BROKE. THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE WAS DEPLOYED AND THE SUTURES SET ASIDE TO PERFORM THE INDEX PROCEDURE. THE SHEATH WAS UPSIZED TO 12 FR AND 18 FR. UPON COMPLETION OF THE AAA REPAIR HEMOSTASIS WAS ACHIEVED WITH THE DEPLOYED PROGLIDE SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE 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 20723J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR, 12FR AND 18FR HEPARIN