BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1664430 · Received April 16, 2010

    Report

    Report Number
    MW5015603
    Event Type
    Injury
    Date Received
    April 16, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CORPORATE HEADQUARTERS
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED AN ANTEGRADE PUNCTURE IN THE COMMON FEMORAL ARTERY. AN ANGIOGRAM WAS THEN PERFORMED WHICH DEMONSTRATED A PROXIMAL HIGH-GRADE ANASTOMOTIC STENOSIS. THE PHYSICIAN THEN PLACED AND PERFORMED AN ANGIOPLASTY WITH A 3-MM BOSTON SCIENTIFIC PERIPHERAL CUTTING BALLOON -LOT # EJ5170- DEVICE NOT LISTED ON FDA'S MEDICAL DEVICE RECALL WEBSITE -HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRES/RES.CFM- AT THE DISTAL VALVE LEAFLET X3. THE BALLOON WAS THEN PULLED BACK TO THE PROXIMAL ANASTOMOSIS AND THIS WAS BALLOONED X2. THE BALLOON WAS THEN PULLED BACK AND A COMPLETION ANGIO SHOWED RESOLUTION OF THE ANASTOMOTIC AND DISTAL VALVE LEAFLET STENOSIS. PER THE OPERATIVE NOTE, ATTEMPT TO PULL THE GRAFT TO REMOVE THE BALLOON WAS DIFFICULT THROUGH THE SHEATH BECAUSE OF THE OBESITY OF THE PT WITH THIS ANTEGRADE PUNCTURE. THE DISTAL MARKER OF THE BALLOON DISCONNECTED FROM THE BALLOON PROPER. THE ENTIRE BALLOON WAS REMOVED, BUT THE MARKER REMAINED. SHEATH AND THE WIRE WERE THEN PULLED BACK, AND REMOVED. F/U FLUOROSCOPY DEMONSTRATED THE MARKER WAS IN SUBCUTANEOUS TISSUE. PLAN IS TO DO A DUPLEX TO ASSESS THE SIGNIFICANCE OF THE FINDING. OPERATIVE PROCEDURE ENDED. VITAL SIGNS STABLE PER SPECIAL PROCEDURES NURSING RECORD. PER OPERATIVE NOTE PT HEMODYNAMICALLY INTACT, AND THE GROIN WAS HEMOSTATIC. DATES OF USE: (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC PERIPHERAL CUTTING BALLOON LIT CORPORATE HEADQUARTERS EJ5170

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability