BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 6203731 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00008
    Event Type
    Injury
    Date Received
    December 25, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    KANEKA CORPORATION
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE CONCERNED BALLOON CATHETER USED WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION, THE DHR WITH LOT NO. SP065063 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESS WAS FOUND. THE LOT PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE SHAFT TENSILE TEST ON REPRESENTATIVE EXTRACTION SAMPLES BASED ON THE SAMPLING PLAN. THE PROBABLE CAUSE OF DEFLATION FAILURE OF THE BALLOON CATHETER IS SPECULATED AS FOLLOWS: THE BALLOON CATHETER WAS PULLED BACK FORCIBLY WHILE THE BALLOON KEPT INFLATING DURING THE ANCHOR-BALLOON TECHNIQUE (CF. B.5), WHICH CAUSED ELONGATION AND NARROWING OF THE OUTER SHAFT PARTIALLY AT PROXIMAL PORTION OF THE BALLOON. WHILE REPOSITIONING THE BALLOON CATHETER TO THE LESION, THE ELONGATION AND NARROWING OF THE CATHETER SHAFT PROGRESSED AND A DEFLATION BECAME IMPOSSIBLE WHEREAS AN INFLATION BY PRESSURIZING WAS STILL POSSIBLE. THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE "SENRI" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.018" GUIDEWIRE COMPATIBLE) IS NOT DISTRIBUTED IN US. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS RX" (RX-TYPE PTA BALLOON DILATATION CATHETER, 0.035" GUIDEWIRE COMPATIBLE) THAT IS DISTRIBUTED IN US UNDER 510(K) # K150865. A GUIDING CATHETER (GC), "PARENT" (6FR , 105CM, STRAIGHT) (MEDIKIT), WAS USED FOR THE APPROACH TOWARD THE LESION OF THE LEFT COMMON ILIAC THROUGH THE RIGHT BRACHIAL ARTERY. A 0.035" GUIDEWIRE(GW), "RADIFOCUS" (TERUMO) CROSSED THE LESION, AND A 6MM X 40MM PTA BALLOON CATHETER, "PROXIMAL LESION BUT NOT THE DISTAL LESION. NEXT, CHANGING INTO A 0.014" SYSTEM, A 0.014" GC, CRUISE (ASAHI INTEC) WAS USED. BUT THE PUSHABILITY OF THE GW WAS NOT ENOUGH, AND THE GW WAS CHANGED TO A 0.018" "SV WIRE" (JOHNSON AND JOHNSON) AND A 7MM X 100MM PTA BALLOON CATHETER, "SENRI" (THE CONCERNED DEVICE) WAS INSERTED INTO THE ARTERY AND INFLATED AND ADVANCED THE GC FURTHER WHILE PULLING BACK THE BALLOON CATHETER (THE ANCHOR-BALLOON TECHNIQUE). THEN, THE BALLOON CATHETER WAS DELIVERED TO THE LESION AND INFLATED AT THE NOMINAL PRESSURE OF 8 ATM. AFTER THAT IT WAS FOUND THAT THE BALLOON CATHETER COULD NOT BE DEFLATED. SINCE THERE WAS NO WAY TO RUPTURE THE INFLATED BALLOON PERCUTANEOUSLY, A SURGICAL REMOVAL WAS PLANNED. HOWEVER, THE OPERATION ROOMS WERE ALL OCCUPIED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND THE DEVICE WAS REMOVED BY A SURGICAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853754 SENRI PTA BALLOON DILATATION CATHETER DQY KANEKA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GUIDEWIRE:SV WIRE(JOHNSON & JOHNSON:0.018" )| GUIDING CATHETER:PARENT(MEDIKIT:6FR. 105CM)