BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3770911 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02557
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - THE LOT NUMBER HAS BEEN CORRECTED FROM 30709K1 TO 30820K1. EVALUATION SUMMARY: THE SUTURE MEDIATED CLOSURE (SMC) SYSTEM WAS RETURNED FOR ANALYSIS. THE REPORTED NEEDLE TO CUFF MISS/SUTURE RETRIEVAL ISSUE WAS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED WITH AN UNSPECIFIED DEVICE. 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248987 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30820K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, HEPARIN