BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2831642 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07170
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    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). LOT NUMBER CORRECTED FROM 20827J1 TO 20830J1. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND THE POSTERIOR CUFF AND NEEDLE TIP WERE ATTACHED TO THE RAIL END. THE LINK WAS STILL ATTACHED TO THE POSTERIOR CUFF. THERE WAS PRESENCE OF A LINK BULB. THE ANTERIOR CUFF WAS ENGAGED TO ANTERIOR NEEDLE TIP. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED AT THE ANTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS PULLED FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A CUFF MISS. BASED ON 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. 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 MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. AFTER WITHDRAWING THE PLUNGER NO SUTURE WAS PRESENT ON THE NEEDLE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20830J1

    Patients

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