BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 2851791 · Received November 30, 2012

    Report

    Report Number
    9612164-2012-01722
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (EVENT MOST LIKELY OCCURRED DURING PROCEDURAL USE, HOWEVER, THE ROOT CAUSE OF EVENT CANNOT BE DETERMINED BASED ON LIMITED INFORMATION AVAILABLE). EVALUATION CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (EVENT MOST LIKELY OCCURRED DURING PROCEDURAL USE, HOWEVER, THE ROOT CAUSE OF EVENT CANNOT BE DETERMINED BASED ON LIMITED INFORMATION AVAILABLE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A 2.75 MM X 12 MM SPRINTER LEGEND RX BALLOON TO PRE-DILATE A LESION IN THE RCA. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE ON THE FIRST ATTEMPT DUE TO A BALLOON PUNCTURE. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE DISTAL TIP WAS SLIGHTLY FLARED. NEGATIVE PURGE CONFIRMED THE PRESENCE OF A LEAK. ON INFLATION THE DEVICE FAILED TO MAINTAIN PRESSURE AND WATER WAS OBSERVED TO LEAK FROM THE DISTAL SECTION OF THE BALLOON. A LONGITUDINAL TEAR WAS VISIBLE BEGINNING AT THE MID-SECTION OF THE BALLOON AND EXTENDING INTO THE DISTAL CONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC TIJUANA 11118429

    Patients

    Seq Age Sex Outcome Treatment
    1