BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1032970 · Received April 9, 2008

    Report

    Report Number
    2953144-2008-00296
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    October 15, 2007
    Report Date
    March 18, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    p960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT INDICATED THE DEVICE WAS NOT AVAILABLE FOR EVAL. THE LOT # WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: OCCLUSION. TIME OF SYMPTOMS/AE: POST VESSEL CLOSURE. INFO REC'D VIA FDA CDRH THAT STATES: PT HAD A CEREBRAL ANGIOGRAM IN 2007. DURING THE NIGHT, THE PT'S RIGHT LEG WAS WEAK. THE NEXT DAY, THE PT'S RIGHT FOOT WAS COOL. PT WAS TAKEN TO THE OPERATING ROOM FOR A THROMBECTOMY OF THE RIGHT ILIAC, COMMON FEMORAL ARTERY RESECTION AND RIGHT LEG FASCIOTOMY. DURING THE OPERATION IT WAS DISCOVERED THAT A PERCLOSE SUTURE HAD GONE THROUGH THE FRONT AND BACK WALL OF THE ARTERY. THE REPORT DID NOT INCLUDE A RPTR OR USER FACILITY NAME. AN ATTEMPT TO OBTAIN FURTHER INFO ON A CUSTOMER CONTACT VIA CDRH WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention