BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4110035 · Received September 23, 2014

    Report

    Report Number
    2024168-2014-06117
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE BREAK WAS CONFIRMED. BASED ON A 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. 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 PERCLOSE PROGLIDE DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER A SUPERFICIAL FEMORAL ARTERY INTERVENTIONAL PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO 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
    589737 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40506K1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SHEATH: 7F, HEPARIN