BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2930231 · Received January 25, 2013

    Report

    Report Number
    2024168-2013-00410
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO PRODUCT DEFICIENCY AND DEVICE WAS NOT RETURNED. THE PATIENT EFFECT OF AN ACCESS SITE INFECTION IS A FORESEEABLE EVENT AND IS A KNOWN POTENTIAL ADVERSE EVENT AS PER THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CEREBRAL ANGIOGRAM ON (B)(6) 2012 AND AFTER A CAROTID STENTING PROCEDURE ON (B)(6) 2012, ARTERIOTOMY CLOSURE WAS ACHIEVED OF THE RIGHT COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. THE OPERATOR REPORTEDLY REGLOVED AND REPREPPED THE PUNCTURE SITE PRIOR TO BOTH CLOSURE PROCEDURES. REPORTEDLY, ONE WEEK LATER AFTER THE CAROTID STENTING PROCEDURE, THE PATIENT PRESENTED WITH PAIN, REDNESS, AND DRAINAGE OF THE RIGHT GROIN AT THE ACCESS SITE. A POSITIVE BLOOD CULTURE CONFIRMED THE VESSEL WAS INFECTED WITH AN UNSPECIFIED BACTERIUM. THE PATIENT WAS PLACED ON A NON-SPECIFIC ANTIBIOTIC AND THE VESSEL WAS SURGICALLY REPAIRED WITH A DEBRIDEMENT, ARTERIAL RESECTION, AND A VEIN GRAFT PATCH. THE VESSEL WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN WAS 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
    36058 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21008J1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R SHEATHS: 6-FRENCH (TWO)