BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 1022750 · Received March 27, 2008

    Report

    Report Number
    9610978-2008-00084
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 14, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT AVAILABLE FOR ANALYSIS AS STATED. ADDITIONAL INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A LONGITUDINAL RUPTURE OCCURRED ON THE INITIAL INFLATION OF THE MAXI LD. THE BALLOON RUPTURED AT 5 ATM. THERE WAS A LEAK OBSERVED. THE PHYSICIAN WAS PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE ABDOMINAL AORTA. THERE WAS NO CALCIFICATION, BUT MILD VESSEL TORTUOUSITY. THE DEVICE WAS USED TO TREAT AN ENDOLEAKAGE FROM AN AAA STENT (ZENITH STENT). AN ENCORE (BOSTON SCIENTIFIC) INDEFLATOR WAS USED. THERE WERE NO PROBLEMS ENCOUNTERED DURING PREP INFLATING AND DEFLATING THE DEVICE. THERE WERE NO OTHER PROBLEMS ENCOUNTERED DURING PREP. THERE WAS NO DIFFICULTY EXPERIENCED TRACKING THE DEVICE TO THE LESION. THERE WERE NO PROBLEMS EXPERIENCED INSERTING THE DEVICE THROUGH THE SHEATH INTRODUCER. THERE WERE NO PROBLEMS ENCOUNTERED WITHDRAWING THE DEVICE. THERE WERE NO OTHER NOTED ANOMALIES. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE MALE PATIENT. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) LIT CORDIS EUROPA, N.V. NA R0807311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ENCORE INDEFLATOR (BOSTON SCIENTIFIC)