BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER RX BALLOON DILATION CATHETER

    MDR report key: 1202443 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00898
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A 1.5 MM X 6 MM SPRINTER RX DILATION BALLOON CATHETER WAS INSERTED INTO A PATIENT, FOR THE TREATMENT OF AN UNKNOWN LESION. THE LESION MORPHOLOGY WAS NOT REPORTED. THE SPRINTER WAS ADVANCED TO THE LESION SITE SUCCESSFULLY. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON AND THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT. AN UNKNOWN BALLOON AND A STENT WERE USED TO COMPLETE THE CASE. NO CLINICAL SEQUELAE WERE REPORTED AND THERE WAS NO INJURY TO THE PATIENT. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE FOLDS ON THE UN-INFLATED BALLOON WERE SLIGHTLY OPEN. THERE WAS NO DAMAGE NOTED TO THE CATHETER. THE DISTAL TIP WAS DAMAGED, INDICATING THAT IT MAY HAVE BEEN STUBBED AGAINST SOMETHING, AS THE BALLOON WAS ADVANCED TO/ACROSS THE LESION. NEGATIVE PURGE CONFIRMED THE PRESENCE OF A LEAK. A TEAR WAS LOCATED DISTAL TO THE MARKER BAND ON THE WORKING LENGTH OF THE BALLOON. THE NATURE OF THE TEAR SUGGESTED THAT THERE MAY HAVE BEEN CALCIFIED PLAQUE PRESENT AT THE LESION SITE, WHICH TORE THE BALLOON MATERIAL, AS THE BALLOON WAS BEING POSITIONED ACROSS THE LESION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE PHYSICIAN CANNOT REMEMBER DETAILS OF THE PATIENT LESION MORPHOLOGY. COMMUNICATIONS FROM THE FIELD CONFIRMED THAT THE BALLOON DID NOT INFLATE, INDICATING THAT THE TEAR MAY HAVE OCCURRED AS THE BALLOON WAS ADVANCED TO/ACROSS THE LESION. ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT CONFIRMED THAT THE DEVICE WAS INSPECTED AND NEGATIVE PREP COMPLETED PRIOR TO USE WITH NO ISSUES NOTED. PLEASE NOTE THAT THIS DEVICE (LOT NUMBER 0000607860) IS DISTRIBUTED OUTSIDE THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER RX BALLOON DILATION CATHETER 74 LOX LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 0000607860

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK