BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER RX BALLOON CATHETER

    MDR report key: 1012462 · Received March 12, 2008

    Report

    Report Number
    2953200-2008-00125
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P970017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 2.0 MM X 15 MM SPRINTER RX DILATATION BALLOON CATHETER WAS USED TO PRE-DILATE AN OM LESION. THE LESION MORPHOLOGY WAS REPORTED TO BE NON-TORTUOUS WITH MODERATE CALCIFICATION AND 95% STENOSIS. THE PHYSICIAN INSERTED THE SPRINTER TO THE LESION SITE. UPON FIRST INFLATION UP TO 4 ATM THE BALLOON WOULD NOT INFLATE. THE SPRINTER BALLOON CATHETER WAS REMOVED SUCCESSFULLY AND POBA COMPLETED THE CASE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO HAVE EXPIRED DUE TO A NON CARDIAC REASON. THE PHYSICIAN CONFIRMED THE PT WAS SUFFERING FROM MULTIPLE DISORDERS. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. AS THE BALLOON PROTECTOR AND STYLETTE WERE REMOVED, AND IT WAS EVIDENT THAT THE STYLETTE HAD BEEN PUSHED UP AGAINST THE DISTAL TIP CAUSING DAMAGE TO THE TIP. THE DISTAL TIP WAS BUNCHED AND THE DISTAL END WAS FLARED. NEGATIVE PURGE INDICATED THE PRESENCE OF A BALLOON LEAK. THE BALLOON WAS INFLATED AND TWO LEAKS WERE NOTED ON THE BALLOON. THE LEAKS WERE LOCATED DISTAL TO THE DISTAL MARKER BAND AND DISTAL TO THE PROXIMAL MARKER BAND ON THE OUTSIDE OF THE FOLD. BOTH LEAKS WERE SMALL RADIAL TEARS. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER RX BALLOON CATHETER 74LOX LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 0000606262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK