BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER RX

    MDR report key: 2860574 · Received December 6, 2012

    Report

    Report Number
    9612164-2012-01752
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: NO RESULTS AVAILABLE. SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A SPRINTER RX DEVICE TO TREAT A LESION, THE SPRINTER WAS INFLATED TO 6ATM AND THE BALLOON BURST DURING PRE-DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1