BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3833639 · Received May 27, 2014

    Report

    Report Number
    2024168-2014-03349
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF OCCURRENCE IS NOT KNOWN. THE ESTIMATED DATE OF (B)(6) 2014 WAS ENTERED AS IT WAS REPORTED TO HAVE OCCURRED IN (B)(6). 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. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED AN ANTEGRADE PUNCTURE WAS PERFORMED IN THE PROCEDURE. IT SHOULD BE NOTED THAT THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE, STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING SPECIAL PATIENT POPULATIONS: PATIENTS WITH ANTEGRADE PUNCTURES. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED NEEDLE TO CUFF MISS 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, 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 AN ILIACA COMMUNIS (AIC) PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK NO BLUE SUTURE WAS ATTACHED TO THE NEEDLE, BUT THE WHITE SUTURE WAS ATTACHED. A SECOND PROGLIDE DEVICE WAS USED AND WHEN THE PLUNGER WAS PULLED BACK THE WHITE SUTURE WAS ATTACHED TO THE NEEDLE AND THE BLUE SUTURE WAS NOT. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. 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
    310455 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30919K1

    Patients

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