BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC INC

    MDR report key: 1410779 · Received July 6, 2009

    Report

    Report Number
    MW5011711
    Event Type
    Malfunction
    Date Received
    July 6, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 6, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR ANGIOPLASTY FROM A NEARBY HOSPITAL DUE TO SEVERE SOB AND CHEST DISCOMFORT. CARDIAC CATH AT THAT FACILITY SHOWED SEVERE GRAFT DISEASE. DURING PTCA PROCEDURE, THE PTCA BALLOON WAS INSERTED FOR THE ANGIOPLASTY. ONCE THE BALLOON ENTERED THE VESSEL THE BALLOON RUPTURED. UPON REMOVAL OF DELIVERY SYSTEM, BALLOON WAS NOT INTACT. BALLOON TIP WAS VISIBLE USING FLUOROSCOPY IN VESSEL. SEVERAL ATTEMPTS WERE MADE WITH SNARES TO RETRIEVE BALLOON TIP. UNABLE TO RETRIEVE BUT MOVED INTO PREVIOUSLY DEAD VESSEL. PROCEDURE COMPLETED. PT STABLE AND ASYMPTOMATIC. PT DISCHARGED HOME IN 2009. PRODUCT: MANUFACTURED BY MEDTRONIC, INC. SPRINTER MX2 1.5MM X 6MM SPRINTER MULTI-EXCHANGE BALLOON DILATATION CATHETER. 1.5MM. REFERENCE: SPR1506MX LOT: 0000579959 2009-09. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CARDIAC PTCA WITH ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC SPRINTER MULTI-EXCHANGE BALLOON DILATATION CATHETER LOX MEDTRONIC, INC. 0000579959

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other