BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3841553 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03494
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 15, 2014
    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 ANALYSIS. THE REPORTED DEVICE OPERATES DIFFERENTLY THAN EXPECTED (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. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. FIVE UNUSED, STERILE REPRESENTATIVE SAMPLES WITH THE LOT NUMBER 40107K1 WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MALFUNCTION OR ABNORMAL OBSERVATIONS WERE DETECTED, BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE, EXACT DATE WAS NOT REPORTED. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. PERFORM A FEMORAL ANGIOGRAM THROUGH THE INTRODUCER SHEATH TO VERIFY THAT THE ACCESS SITE IS IN THE COMMON FEMORAL ARTERY. TO AVOID POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY, FLUOROSCOPICALLY EVALUATE THE FEMORAL ARTERY FOR SIZE, CALCIUM, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PROGLIDE DEVICE WITH A 5F SHEATH AFTER AN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER NEEDLE DEPLOYMENT THE PLUNGER WAS RETRACTED, AN ANTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO FEMORAL ANGIOGRAM OR OTHER IMAGING WAS TAKEN. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318623 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40107K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5F, HEPARIN