BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1101949 · Received August 6, 2008

    Report

    Report Number
    9610978-2008-00200
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER THE ENGINEER HAS NOT COMPLETED THE ANALYSIS AS OF TO DATE. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE BALLOON CATHETER COULD NOT BE INFLATED AND SUBSEQUENTLY, WITHDRAWAL DIFFICULTY WAS ENCOUNTERED. THIS WAS A CROSSOVER PROCEDURE (FEMORAL ACCESS) WITH TERUMO 5 FRENCH SHEATH AND COOK 0.018" ROADRUNNER GUIDEWIRE. SAVVY COULD NOT BE INFLATED AND THEREFORE, IT WAS WITHDRAWN. HOWEVER, WHILE TRYING TO WITHDRAW THE SAVVY BALLOON CATHETER THROUGH SHEATH, IT WAS NOTED THAT THIS WAS NOT COMPLETELY POSSIBLE. THEREFORE, THE BALLOON CATHETER AND THE SHEATH WERE WITHDRAWN AS A SINGLE UNIT WITHOUT INCIDENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0607398

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COOK 0.018" ROADRUNNER GUIDEWIRE| TERUMO 5 FRENCH SHEATH