BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX

    MDR report key: 3924690 · Received July 10, 2014

    Report

    Report Number
    9612164-2014-00781
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    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: RELATED TO OPERATIONAL CONTEXT - BALLOON BURST IS MOST LIKELY PROCEDURAL RELATED. PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE - LESION MORPHOLOGY (90% STENOSIS AND MODERATE CALCIFICATION). (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT - BALLOON BURST IS MOST LIKELY PROCEDURAL RELATED. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION - LESION MORPHOLOGY (90% STENOSIS AND MODERATE CALCIFICATION). (B)(4)

    Description of Event or Problem · 1

    DURING OPERATION, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE ONE NC SPRINTER BALLOON (2.75MM X 21MM) AT 10 ATM, THE BALLOON WAS RUPTURED ON THE SECOND INFLATION. FIRST INFLATION WAS SUCCESSFULLY COMPLETED BY USING THE RELEVANT DEVICE AT 10 ATM FOR ABOUT 30 SECONDS. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE FOR THE SECOND INFLATION, THE BALLOON WAS RUPTURED BELOW 10 ATM. IT WAS UNKNOWN WHETHER THE RELEVANT BALLOON WAS REMOVED FROM THE PATIENT AFTER THE FIRST INFLATION. PATIENT WAS TREATED WITH UNKNOWN STENT. NO HEALTH HAZARD WAS OCCURRED TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: PATENCY OF THE INNER LUMEN WAS CHECKED BY INSERTING A 0.015¿¿ MANDREL INTO THE WIRE LUMEN ENTRY PORT THROUGH TO THE TIP OF THE DEVICE, THERE WAS NO RESISTANCE NOTED WHEN THIS WAS PERFORMED. THE DISTAL TIP OF THE BALLOON WAS SLIGHTLY DAMAGED. ANALYSIS OF THE BALLOON SHOWED WHAT COULD BE A SLIGHT PINHOLE ON THE OUTER BALLOON. DURING THE ANALYSIS THE DEVICE FAILED NEGATIVE PREP. THE BALLOON WAS INFLATED WITH WATER, THE BALLOON WOULD NOT MAINTAIN PRESSURE AND WATER WAS LEAKING FROM THE DISTAL SECTION OF THE BALLOON. THE MIDDLE AND PROXIMAL SECTION OF THE BALLOON HAD NO ABNORMALITIES NOTED. THERE WAS NO OTHER DAMAGE NOTED ALONG THE CATHETER LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403481 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 208162729

    Patients

    Seq Age Sex Outcome Treatment
    1