BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANEKA PTA CATHETER PE-R3, RX-GENITY

    MDR report key: 6203735 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00014
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 6, 2016
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR- BATCH RECORD) OF THE KANEKA PTA CATHETER PE-R3, RX-GENITY, WITH LOT NO. SP045305 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. THE LOT PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE BALLOON-REPETITIVE INFLATION/DEFLATION TEST, THE SHAFT-PRESSURIZED TEST FOR EVERY PRODUCT AND THE FINISHED PRODUCT INSPECTIONS INCLUDING SHAFT TENSILE STRENGTH TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. THE CONCERNED USED DEVICE WAS RETURNED AND INVESTIGATED: THE BALLOON WAS TORN APART AT 46MM FROM THE DISTAL TIP, AND THERE WAS A TRACE OF TEAR EXTENDING IN THE LONG AXIAL DIRECTION BETWEEN 26MM FROM THE DISTAL TIP AND THE TORN-OFF EDGE OF THE BALLOON. THE INNER SHAFT WAS ELONGATED AND TORN OFF AT 6MM FROM THE DISTAL TIP. IT WAS CONFIRMED THAT ALL THE TORN-OFF AND REMAINED-IN-THE-PATIENT PORTION WAS RECOVERED OUT OF THE PATIENT, SINCE NONE OF THE ENTIRE STRUCTURE OF THE DEVICE WAS FOUND MISSING IN THE RETURNED PRODUCT. PROBABLE CAUSE AND COMMENTS: THE BALLOON WAS INJURED WITH THE HIGHLY CALCIFIED AND HARDENED LESIONS AND BURST BY THE STRESS OF INFLATION. WHILE PULLING BACK THE CATHETER, THE RUPTURED AND BULKY BALLOON PORTION COULD NOT ENTER INTO THE GUIDING SHEATH, AND THE BALLOON AND THE INNER SHAFT WERE TORN OFF WITH EXCESSIVE FORCE LOADED BY FURTHER ATTEMPT TO PULL BACK FORCIBLY. THE REPORTED PROBLEM IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE. "THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION."

    Description of Event or Problem · 1

    THE CONCERNED DEVICE "KANEKA PTA CATHETER PE-R3, RX-GENITY" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.018" GUIDEWIRE(GW) COMPATIBLE) IS NOT DISTRIBUTED IN US. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "CROSSTELLA RX" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.018" GW COMPATIBLE) THAT IS DISTRIBUTED IN US UNDER 510(K) #K152873. THIS DEVICE WAS APPLIED TO A PTA OF HIGHLY CALCIFIED LESIONS IN THE POPLITEAL ARTERY AND THE SUPERFICIAL FEMORAL ARTERY THROUGH THE COMMON FEMORAL ARTERY OF A MALE PATIENT. AFTER THE 8TH DILATATION IN THE LESIONS, THE BALLOON BURST. WHILE ATTEMPTED TO RETRIEVE THE DEVICE FROM THE PATIENT, THE PHYSICIAN NOTICED ABNORMAL AND FOUND THAT THE BALLOON PORTION WAS BROKEN APART AND REMAINED IN THE PATIENT'S ARTERY. THE PHYSICIAN TRIED TO REMOVE THE BROKEN PORTION FROM THE PATIENT'S ARTERY BY USING A SNARE DEVICE, BUT FAILED SINCE IT WITH THE SNARE DEVICE STUCK NEAR THE PUNCTURE-SITE IN THE RIGHT ARM. THE PHYSICIAN ASKED A SURGEON FOR A SURGICAL REMOVAL, AND IT WAS SUCCESSFULLY TAKEN OUT BY THE INCISION OF THE RIGHT UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853756 KANEKA PTA CATHETER PE-R3, RX-GENITY PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SP045305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R GUIDEWIRE SPINDLE XS 0.7| SHEATH 5FR DESTINATION