BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATION CATHETER

    MDR report key: 2060803 · Received March 10, 2011

    Report

    Report Number
    9612164-2011-00030
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: METHOD: X-RAY, FLUOROSCOPY, IVUS, CT, MRI ETC. RESULTS: LESION MORPHOLOGY. CONCLUSION: LESION MORPHOLOGY. EVALUATION SUMMARY: THE BALLOON FOLDS WERE OPENED. SCRATCH MARKS AND CREASES WERE EVIDENT ON THE BALLOON. PINHOLE WAS NOTED OVER MARKERBAND. CD REVIEW: CD IMAGES SHOW SIGNIFICANT STENOSIS AT THE LESION SITE. THERE ARE IMAGES OF A BALLOON WITH A SINGLE MARKER BAND BEING POSITIONED OVER THE LESION AND INFLATED; HOWEVER, THERE IS NO EVIDENCE OF A BALLOON BURST. THE CD IMAGES ALSO SHOW A STENT BEING DEPLOYED FOLLOWED BY ADDITIONAL PRE-DILATIONS IN A MORE DISTAL LESION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A 1.5 MM DIAMETER X 12 MM LENGTH SPRINTER LEGEND RX BALLOON DILATION CATHETER TO PRE-DILATE A LESION IN THE PROXIMAL LAD. IT WAS REPORTED THAT THE BALLOON BURST WHILE USING NORMAL PRESSURE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. INFORMATION STATES THAT THE SPRINTER LEGEND DEVICE HAD TO PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATION CATHETER LOX MEDTRONIC TIJUANA NA 10946061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK