BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER OTW BALLOON CATHETER

    MDR report key: 1052513 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00356
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: LACK OF INFO.

    Description of Event or Problem · 1

    A 1.5 MM DIAMETER X 12 MM LENGTH SPRINTER BALLOON WAS INSERTED IN A PT FOR TREATMENT OF AN UNK LESION. LESION MORPHOLOGY WAS REPORTED AS CALCIFIED. IT WAS REPORTED THAT THE SPRINTER BALLOON WAS INSERTED TO THE LESION SITE AND INFLATED TO 5 ATM; THE BALLOON BURST. THE BALLOON CATHETER WAS SUCCESSFULLY REMOVED. (MFR REPORT# 2953200-2008-00357) A SECOND SPRINTER 1.5 X 15 WAS INSERTED TO THE LESION SITED AND INFLATED TO 8 ATM; THE BALLOON BURST. THE BALLOON CATHETER WAS SUCCESSFULLY REMOVED. A THIRD SPRINTER 1.5 X 15 WAS INSERTED TO THE LESION SITE; WHICH SUCCESSFULLY DILATED THE LESION. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER OTW BALLOON CATHETER 74 LOX LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 0000675830

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK