BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 9697148 · Received February 11, 2020

    Report

    Report Number
    3002808904-2020-00003
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 17, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. SINCE THE ACTUAL DEVICE WAS NOT RETUNED, WE INVESTIGATED THE DEVICE HISTORY RECORDS. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE VISUAL TEST, SHAFT PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. THE PROTECTIVE MATERIAL FOR THE BALLOON WAS LEFT ON THE BALLOON DURING PREPARATION OF THE BALLOON, AND INADVERTENTLY INSERTED INTO THE PATIENT. IN ADDITION, IFU HAS THE FOLLOWING NOTES: [OPERATION METHOD OR INSTRUCTIONS FOR USE] PREPARATIONS: AFTER ASEPTICALLY REMOVING THIS CATHETER FROM THE PACKAGE CONTAINER, DETACH THE PROTECTIVE MATERIALS.

    Description of Event or Problem · 1

    A (B)(6) GENTLEMAN HAD AN ANGIOPLASTY OF HIS POPLITEAL ARTERY, LEFT LOWER LOBE. PATIENT HAS LEFT HALLAX ULCER AND LEFT DIABETIC FOOT DISEASE. CLINICIANS PROCEEDED TO DO ANGIOPLASTY OF THE LEFT DISTAL POPLITEAL ARTERY, THEY INITIALLY INSERTED A CORDIS BALLOON 2MMX100MM POST ANGIOPLASTY WITH GOOD RESULT BUT DECIDED TO USE A SENRI BALLOON 2MMX150MM ASWELL AS THEY WANTED TO OPEN UP MORE OF THE DISTAL POPLITEAL ARTERY. THE CONSULTANT USED THE SENRI BALLOON 2MM X150MM WITH NO APPARENT PROBLEM. GOOD RESULT POST ANGIOPLASTY. ON (B)(6) 2020 GENTLEMAN WAS SEEN BY DR. (B)(6) AS PATIENT CIRCULATION HAD NOT IMPROVED THEREFORE, A REPEAT ANGIOGRAM WAS PERFORMED AND DR. (B)(6) SAW THAT FLOW TO THE SUPERIOR FEMORAL ARTERY WAS GOOD BUT BELOW THE KNEE THERE WAS A CURIOUS APPEARANCE/POSSIBLE DISSECTION FROM OCCLUDED POSTERIOR TIBIAL ORIGIN INTO THE BELOW THE KNEE POPLITEAL. DR. (B)(6) DECIDED TO CONTACT THE VASCULAR SURGEONS WHO DID AN ULTRASOUND DOPPLER AND COULD SEE WHAT THEY THOUGHT WAS ???STENT OR ???TUBE. THE OBJECT WAS REMOVED SURGICALLY AND IT WAS DISCOVERED THAT IT WAS THE TRANSLUCENT BALLOON COVER OF A SENRI BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157842 SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION SP069459

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other