BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2061434 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02709
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    October 10, 2010
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.: ESTIMATED DATE OF GROIN EXPLORATION (REPORTED AS A FEW WEEKS AGO) THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED. IT SHOULD BE NOTED THAT A FAILURE OF THE DEVICE HAS NOT BEEN REPORTED. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF AN ISSUE WITH THE QUALITY OF THE PRODUCT AND A DEFINITIVE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THREE MONTHS AFTER UNEVENTFUL CLOSURE, THE PATIENT DEVELOPED TENDERNESS, REDNESS, AND A PEA SIZED KNOT AT THE GROIN SITE WHICH WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. A MONTH LATER, THE SITE REMAINED TENDER WITH REDNESS. THE PATIENT HAS BEEN EVALUATED BY A VASCULAR SURGEON AND A BIOPSY WAS PERFORMED REMOVING ENCAPSULATED PUS FROM THE LEFT GROIN TISSUE AREA. THE ENCAPSULATED PUS WAS FOUND IN THE LEFT GROIN TISSUE AREA AND NOT IN OR ON THE ARTERY. THE ARTERY AROUND THE PROGLIDE SUTURE WAS REPORTED TO BE HEALTHY. THE PHYSICIAN STATED THAT THE ENCAPSULATED PUS COULD POTENTIALLY HAVE BEEN A RESULT OF A DAMAGED LYMPH NODE WHICH COULD HAVE CAUSED AN INFECTION. THE PATIENT HAS RECOVERED AND THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, NO ADDITION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention