BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3023272 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01749
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED DEVICE REVEALED THE LINK WAS DETACHED AT THE SWAGE END OF THE POSTERIOR CUFF DURING THE NEEDLE PLUNGER RETRACTION RESULTING IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR SIMILAR TO THE REPORTED CUFF MISS. 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. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT PERFORMED. PER THE PROGLIDE INSTRUCTIONS FOR USE: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). FEMORAL ANGIOGRAM WAS NOT TAKEN TO VERIFY THE LOCATION OF THE PUNCTURE SITE. PER THE INSTRUCTIONS FOR USE - PERFORM A FEMORAL ANGIOGRAM TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. 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 AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 5F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE NEEDLES WERE DEPLOYED, ONLY THE LINK WAS PRESENT; A CUFF MISS OCCURRED. THE VESSEL WAS RE-WIRED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO FEMORAL ANGIOGRAM WAS PERFORMED PRIOR TO THE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127036 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30111J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5F TERUMO RADIFOCUS