BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 1071586 · Received July 7, 2008

    Report

    Report Number
    9610978-2008-00167
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS REVIEW WAS EXTENDED TO SUBASSEMBLIES, AND CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN AS WELL.

    Description of Event or Problem · 1

    DURING POST-DILATATION OF A PRECISE PLACED IN THE AORTIC ISTHMUS OF A MALE PT, THE 4X18 MAXI LD BALLOON COULD NOT BE DEFLATED FULLY AND DURING THE ATTEMPT TO WITHDRAW IT BACK THROUGH THE CSI, DIFFICULTY WAS EXPERIENCED. THE BALLOON THEN WAS SURGICALLY REMOVED BY ARTERIAL CUT-DOWN AT THE INSERTION SITE. THE STENT REMAINED IN ITS DESIRED LOCATION, AND THE PT'S STATUS WAS NOTED AS STABLE. AN INDEFLATOR WAS USED. THE BALLOON WAS SAVED AND WILL BE RETURNED FOR STABLE. AN INDEFLATOR WAS USED. THE BALLOON WAS SAVED AND WILL BE RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT THE MAXI BALLOON WAS PAST ITS UBD WHEN USED. THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, THE ENGINEERING EVAL HAS NOT BEEN COMPLETED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 R1106213

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention 12F COOK CSI| 10F TERUMO CSI