BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TASUKI

    MDR report key: 8673739 · Received June 6, 2019

    Report

    Report Number
    3002808904-2019-00011
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 14, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE CONCERNED WAS RETURNED AND INVESTIGATED: A DAMAGE AND A THROUGH HOLE WERE CONFIRMED AT 18.5 MM FROM THE TIP OF THE CATHETER. ABNORMALITY IN APPEARANCE WAS NOT CONFIRMED EXCEPT FOR THE BALLOON PORTION. THE DEVICE HISTORY RECORDS(DHR)OF THE DEVICE WAS REVIEWED: IN THE MANUFACTURING PROCESS, IT HAS BEEN CONFIRMED THAT THERE ARE NO PRESSURE DROP IN ALL PRESSURE AND AIR TIGHTNESS TESTS. IN ADDITION, NO ABNORMAL POINTS WERE FOUND IN OTHER IN-PROCESS INSPECTIONS, INCLUDING RAW MATERIAL ACCEPTANCE INSPECTION, DIMENSIONAL INSPECTION AND VISUAL INSPECTION OF THE SHAFT. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS PRESUMED THAT BALLOON DILATATION OF A HIGHLY CALCIFIED LESION CAUSED ACCIDENTAL DISSOCIATION OF THE PINHOLE RUPTURE, RESULTING IN VASCULAR DISSOCIATION. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND, AND ACCORDINGLY, WE DETERMINE THAT THE EVENT REPORTED WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "TASUKI", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NO DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "RX NC TAKERU PTCA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K170941. THE OPERATOR ABLATED THE HIGHLY CALCIFIED LESION OF LAD # 6 WITH A 70-79% DEGREE OF STENOSIS USING A ROTABLATOR 1.5 MM. THE LESION WAS THEN DILATED USING A WOLVERINE CORONARY CUTTING BALLOON 2.5 MM ?~ 10 MM BUT THE BALLOON RUPTURED. NEXT, A NC TREK PTCA BALLOON CATHETER 2.75 MM ?~ 15 MM WAS USED FOR DILATATION OF THE LESION BUT AGAIN THE BALLOON RUPTURED. AFTER THAT THE LESION COULD BE EXPANDED USING THE TASUKI PTCA BALLOON CATHETER, HOWEVER THE BALLOON OF THE CATHETER CAUSED PIN-HOLE RUPTURE AND THE VASCULAR DISSECTION WAS OCCURRED. FOR THE PURPOSE OF HEMOSTASIS A LONG INFLATION IN THE BLOOD VESSEL USING A RYUSEI PERFUSION BALLOON CATHETER 2.5 MM X 20 MM WAS PERFORMED, AND THEN IT BECAME POSSIBLE TO BAIL OUT BY PLACING A ALCHIMASTER STENT 3.0 MM X 38 MM IN THE VASCULAR DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468406 TASUKI CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP049217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R