BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2210439 · Received August 8, 2011

    Report

    Report Number
    9612164-2011-00903
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (PATIENT VESSEL MORPHOLOGY, LESION WAS SEVERELY CALCIFIED AND TORTUOUS), (DISSECTION). EVALUATION: CONCLUSION: (PATIENT VESSEL MORPHOLOGY, LESION WAS SEVERELY CALCIFIED AND TORTUOUS).

    Description of Event or Problem · 1

    THE PHYSICIAN USED SPRINTER LEGEND RX BALLOON DILATATION CATHETER TO PRE-DILATE A LESION THAT EXHIBITED SEVERE CALCIFICATION AND WAS REPORTED TO BE LOCATED IN A TORTUOUS VESSEL. POST DILATATION WITH THE SPRINTER LEGEND RX DEVICE, THE DOCTOR REPORTED THAT A DISSECTION OF THE VESSEL OCCURRED. THE DISSECTION WAS TREATED WITH THE SUCCESSFUL IMPLANTATION OF AN ENDEAVOR RESOLUTE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC TIJUANA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention