BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND OTW

    MDR report key: 2882939 · Received December 21, 2012

    Report

    Report Number
    9612164-2012-01824
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    K103095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW.(B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED AND THE REPORTED INFLATION DIFFICULTIES ARE UNCONFIRMED. DEVICE PERFORMED ACCORDING TO SPECIFICATIONS -THE BALLOON WAS SUCCESSFULLY INFLATED DURING EVALUATION OF THE RETURNED DEVICE. EVALUATION CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED , CAUSE OF EVENT UNKNOWN -THE BALLOON WAS SUCCESSFULLY INFLATED DURING EVALUATION OF THE RETURNED DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A SPRINTER LEGEND OVER THE WIRE BALLOON; HOWEVER, THE BALLOON WOULD NOT INFLATE. NO CLINICAL SEQUELAE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED. VISUAL INSPECTION CONFIRMED THERE WAS NO STRETCHING/NECKING OF THE INFLATION LUMEN OR THE PROXIMAL BALLOON BOND THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ATTEMPTS TO INFLATE THE BALLOON FAILED POSSIBLY DUE TO THE CRYSTALLIZED RESIDUE, MOST LIKELY CONTRAST SOLUTION; PRESENT IN THE INFLATION LUMEN AND BALLOON. THE DEVICE WAS PLACED IN A WATER BATH TO DISPERSE THE RESIDUE PRESENT IN THE INFLATION LUMEN AND BALLOON. FOLLOWING REMOVAL FROM THE WATER BATH, NEGATIVE PURGE WAS PERFORMED WITH NO ISSUES NOTED; CONFIRMING THAT THERE WAS NO LEAK PRESENT ON THE DEVICE. THE BALLOON WAS CONDITIONED IN THE WATER BATH AT 37+/-2 DEGREES CELSIUS AND THE BALLOON WAS SUCCESSFULLY INFLATED TO NOMINAL PRESSURE WITH NO ISSUES BEING OBSERVED. THERE WERE NO ISSUES EXPERIENCED ATTACHING OR DETACHING THE INFLATION DEVICE TO THE LUER OF THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND 0005685919

    Patients

    Seq Age Sex Outcome Treatment
    1