BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX

    MDR report key: 3111280 · Received May 14, 2013

    Report

    Report Number
    9612164-2013-00532
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (LESION MORPHOLOGY) - CALCIFIED LESION WITH 80% STENOSIS EVALUATION CONCLUSIONS: (LESION MORPHOLOGY) - CALCIFIED LESION WITH 80% STENOSIS. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DILATE A SEVERELY CALCIFIED LESION IN THE LAD WITH 80% STENOSIS WITH ONE NC SPRINTER BALLOON BUT THE BALLOON RUPTURED AT 1ST DILATION WITH 12ATMS/5SEC, PRIOR TO THIS A NON-MEDTRONIC BALLOON RUPTURED ON ITS 2ND DILATION. PATIENT WAS SUCCESSFULLY TREATED WITH ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT. NO ABNORMALITY NOTED DURING APPLYING NEGATIVE PRESSURE PRIOR TO USE. NO RESISTANCE NOTED WITH THE LESION / ANOTHER DEVICE. NO PATIENT INJURY REPORTED. PRODUCT EVALUATION: THE BALLOON HAD BEEN INFLATED. HARDENED BLOOD AND CONTRAST WERE PRESENT INSIDE THE INFLATION LUMEN AND BALLOON. THE DEVICE WAS PLACED IN A 37 DEGREE CELSIUS WATERBATH FOR 24 HOURS TO SOFTEN THE HARDENED CONTRAST AND BLOOD TO FACILITATE BALLOON INFLATION. THE DEVICE FAILED NEGATIVE PREP. PRESSURE WAS APPLIED TO THE DEVICE AND LIQUID WAS SEEN EXITING THE BALLOON. A SMALL RADIAL TEAR WAS LOCATED ON TOP OF A BALLOON FOLD AT THE DISTAL END OF THE BALLOON WORKING LENGTH. NUMEROUS SCRATCHES WERE PRESENT ALONG THE BALLOON WORKING LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213409 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 206528513

    Patients

    Seq Age Sex Outcome Treatment
    1