BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC SPRINTER RX BALLOON DILATATION CATHETER

    MDR report key: 2100442 · Received May 17, 2011

    Report

    Report Number
    9612164-2011-00446
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 16, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS/CONCLUSION: (ROOT CAUSE OF THE EVENT CANNOT BE CONFIRMED BASED ON INFO AVAILABLE). EVAL SUMMARY: A 3.5 X 21MM NC SPRINTER RX BALLOON DILATATION CATHETER: HYPOTUBE WAS BENT AND WAVY. THE TRANSITION TUBING WAS STRETCHED AND HAD DETACHED 17CM DISTAL TO THE HYPO TUBE BOND. THERE WAS 1.5CM OF THE CORE WIRE EXPOSED DISTAL TO THE DETACHMENT SIDE. DISTAL INNER AND OUTER SHAFTS, BALLOON AND DISTAL TIP HAD DETACHED.

    Description of Event or Problem · 1

    PHYSICIAN USED A 3.5MM DIAMETER X 21MM LENGTH NC SPRINTER RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER AS PART OF A KISSING BALLOON TECHNIQUE TO POST-DILATE A STENT LOCATED IN A BIFURCATION OF THE LAD AND A DIAGONAL. HOWEVER, IT WAS REPORTED THAT WHILE REMOVING FROM THE PT, RESISTANCE WAS FELT AND BALLOON MATERIAL AND PART OF THE SHAFT OF THE NC SPRINTER RX DEVICE DETACHED, REMAINING IN THE PT. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED MATERIAL; HOWEVER, ALL UNSUCCESSFUL, THEREFORE, THE PT WAS SENT TO SURGERY. NO OTHER CLINICAL SEQUELAE WERE REPORTED. A SECOND NC SPRINTER RX BALLOON DILATATION CATHETER USED DURING THIS PROCEDURE WAS ALSO RETURNED FOR EVAL (2.5X27MM BALLOON). ON INSPECTION OF THIS DEVICE, THE SHAFT WAS NOTED TO BE SEVERELY STRETCHED AND THE GUIDE WIRE ENTRY PORT WAS RIPPED. A CATHETER LEAK WAS DETECTED. REFERENCE MFR REPORT#: 9612164-2011-00445.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC SPRINTER RX BALLOON DILATATION CATHETER LOX MEDTRONIC IRELAND NA 0001248420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention