BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3955347 · Received July 24, 2014

    Report

    Report Number
    2024168-2014-04745
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED NEEDLE TO CUFF MISS/SUTURE RETRIEVAL ISSUE 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE, PLACEMENT OF THE SUTURES USING THE PRECLOSE TECHNIQUE WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY WITH A PROGLIDE DEVICE. REPORTEDLY, WHEN PRESSING THE NEEDLE PLUNGER TO PUSH THE NEEDLES OUT OF THE PROXIMAL GUIDE, THE EXPECTED CLICK WAS NOT HEARD. THE NEEDLES WERE PULLED OUT A FEW MILLIMETERS AND PUSHED BACK IN. THE CLICK WAS NOT HEARD. WHEN THE NEEDLES WERE REMOVED ONLY THE WHITE SUTURE WAS PRESENT AT THE NEEDLES. NO BLUES SUTURE WAS SEEN. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY PLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 8F. THE SHEATH WAS UPSIZED TO 16F FOR THE AAA PROCEDURE. AFTER COMPLETION OF THE AAA PROCEDURE, THE TWO SUCCESSFULLY PREPLACED SUTURES ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. A TRAINED PHYSICIAN WAS PRESENT IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433334 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31119K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8F, 16F