BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER OTW

    MDR report key: 2992100 · Received March 7, 2013

    Report

    Report Number
    9612164-2013-00256
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM -RADIAL TEARS. RELATED TO OPERATIONAL CONTEXT - ROOT CAUSE OF ISSUE IS MOST LIKELY PROCEDURAL RELATED EVALUATION CODES CONCLUSION: 77 RELATED TO OPERATIONAL CONTEXT - ROOT CAUSE OF ISSUE IS MOST LIKELY PROCEDURAL RELATED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A SPRINTER OVER THE WIRE (OTW) BALLOON TO TREAT A LESION IN THE MID DIAGONAL WHICH WAS REPORTED TO BE A VERY TIGHT LESION WITH 70% STENOSIS. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE. AFTER APPLYING PRESSURE OF 14ATM FOR 6 SECS THE BALLOON BURST. INFORMATION PROVIDED CONFIRMS THAT RESISTANCE WAS FELT AS THE DEVICE WAS ADVANCED THROUGH THE LESION. PATIENT IS DOING WELL POST PROCEDURE. EVALUATION SUMMARY: THE BALLOON HAD BEEN PARTIALLY INFLATED. THE DEVICE FAILED NEGATIVE PREP. PRESSURE WAS APPLIED TO THE DEVICE AND LIQUID WAS SEEN EXITING THROUGH TWO RADIAL TEARS ON THE BALLOON. TWO RADIAL TEARS WERE LOCATED JUST DISTAL TO THE MARKER BAND ON THE BALLOON WORKING LENGTH. THE TEARS WERE APPROXIMATELY 0.5MM IN LENGTH AND WERE LOCATED ON TOP OF THE BALLOON FOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97879 SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND 0006176365

    Patients

    Seq Age Sex Outcome Treatment
    1