BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND BALLON DILATATION CATHETER

    MDR report key: 1191507 · Received September 25, 2008

    Report

    Report Number
    2953200-2008-00868
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P970017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: SEVERE CALCIFICATION AND 75% STENOSIS. CONCLUSIONS: SEVERE CALCIFICATION AND 75% STENOSIS. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE HYPOTUBE WAS BENT POSSIBLY DUE TO COILING FOR RETURN. THE GUIDE WIRE ENTRY PORT WAS RIPPED, MOST LIKELY DUE TO THE HANDLING OF THE GUIDE WIRE DURING THE PROCEDURE. THE BALLOON HAD BURST WITH A LONGITUDINAL TEAR EVIDENT ON THE BALLOON. THERE WAS NO OTHER DAMAGE EVIDENT ON THE RETURNED DEVICE. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD CONFIRMED THAT THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO DIFFICULTIES WERE ENCOUNTERED DURING INFLATION OF THE DEVICE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNTIED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    A 2.5 MM X 10 MM SPRINTER LEGEND RX DILATATION BALLOON CATHETER WAS INSERTED TO PRE-DILATE AN LAD LESION. VESSEL MORPHOLOGY WAS REPORTED TO BE SEVERE CALCIFICATION AND 75% STENOSIS. THE PHYSICIAN INSERTED AN IVUS CATHETER; HOWEVER WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE BALLOON WAS ADVANCED TO THE INTENDED LESION SITE AND INFLATED THREE TIMES TO 14 ATM; HOWEVER, THE LESION WAS NOT FULLY DILATED. THE SPRINTER LEGEND WAS INFLATED TO 16 ATM, WHICH IS 2 ATM OVER RATED BURST OF PRESSURE, AND THE LESION WAS CONFIRMED TO BE DILATED. HOWEVER, THE BALLOON BURST AT 16 ATM AND A DISSECTION OCCURRED. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO FURTHER INTERVENTION WAS PERFORMED AND THE CASE WAS COMPLETED. THE PHYSICIAN PLANS TO PERFORM ROTABLATOR AND STENT DEPLOYMENT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND BALLON DILATATION CATHETER 74LOX LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 9915155

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR