BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHSTAR XL 6 FR PVS

    MDR report key: 166606 · Received May 7, 1998

    Report

    Report Number
    2953144-1998-00041
    Event Type
    Injury
    Date Received
    May 7, 1998
    Date of Event
    March 12, 1998
    Report Date
    April 13, 1998
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT SUCCESSFUL ARTERIOTOMY CLOSURE WITH A TECHSTAR XL 6 FR PVS DEVICE. AT HOME, SEVERAL DAYS LATER, THE PT BENT OVER TO PICK SOMETHING UP, HEARD A "POP" AND NOTED BLEEDING AT THE GROIN SITE. HE PRESENTED AT THE EMERGENCY ROOM AND WAS TAKEN FOR SURGICAL REPAIR OF A PSEUDONAEURYSM. THE PT RETURNED TO SURGERY AT A LATER DATE FOR ABOVE THE KNEE AMPUTATION RELATED TO SEVERE PERIPHERAL VASCULAR DISEASE (PVD) AND COMPROMISED CIRCULATION TO THE LEG. THE PHYSICIANS DID NOT ATTRIBUTE THE COMPROMISED CIRCULATION TO THE PSEUDOANEURYSM, BUT TO NOT DOING A FEMORAL ARTERY RESECTION IN TREATMENT OF THE PVD AT THE TIME OF THE PSEUDOANEURYSM REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHSTAR XL 6 FR PVS PERCUTANEOUS VASCULAR SURGICAL MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention NONE REPORTED.