BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK-X CATHETER

    MDR report key: 2440449 · Received January 19, 2012

    Report

    Report Number
    1318694-2012-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 15, 2011
    Report Date
    January 18, 2012
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K0227220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE CATHETER WAS PULLED INTO THE INTRODUCER BEFORE THE BALLOON WAS FULLY DEFLATED. THIS CAUSED A STRETCHING OF THE CATHETER SHAFT AND FULLY SEALED OFF THE INFLATION LUMEN. AS PER THE INSTRUCTIONS FOR USE: "BEFORE REMOVING THE CATHETER FROM THE SHEATH, IT IS VERY IMPORTANT THAT THE BALLOON IS COMPLETELY DEFLATED." A COMPARATIVE CATHETER WAS PULLED FROM INVENTORY AND TESTED FOR INTRODUCER ADMITTANCE AS WELL INFLATION/DEFLATION TIMES. THE COMPARATIVE CATHETER PERFORMED WITHIN SPECIFICATIONS FOR BOTH THE INTRODUCER AND INFLATION/DEFLATION TIMES. THE INFLATION/DEFLATION TIMES WERE WELL BELOW THE TIMES SUBMITTED IN THE 510K APPLICATION.

    Description of Event or Problem · 1

    AS REPORTED TO THE REP: THE BALLOON WAS SLOW TO DEFLATE, COULD NOT GET IT BACK THROUGH THE SHEATH. THE PHYSICIAN HAD TO GO IN WITH A SNARE TO RETRIEVE IT. AS REPORTED IN THE MDR FROM THE FACILITY: RIGHT FEMORAL ARTERY AND VENOUS ACCESS OBTAINED. BALLOON VALVULOPLASTY PERFORMED. THE BALLOON WAS DIFFICULT TO DEFLATE AND ONCE DEFLATED COULD NOT BE REMOVED REQUIRING A LOOP SNARE THROUGH A 9FR SHEATH IN THE LEFT FEMORAL ARTERY. THE BALLOON WAS THEN SUCCESSFULLY REMOVED. PHYSICIAN NOTES A SMALL LEFT INTERNAL ILIAC ARTERY INTIMAL INJURY THOUGHT TO BE W/O SIGNIFICANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK-X CATHETER PTV CATHETER LIT NUMED, INC. 102X TX-0211

    Patients

    Seq Age Sex Outcome Treatment
    1