BEUDAMED
    FDA Adverse Event Death Summary report: N

    KANEKA PTCA CATHETER ZINRAI

    MDR report key: 21291947 · Received February 3, 2025

    Report

    Report Number
    3002808904-2025-00002
    Event Type
    Death
    Date Received
    February 3, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 9, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "ZINRAI", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "RX TAKERU PTCA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K163372. 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 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 ACTUAL DEVICE WAS NOT RETURNED AND COULD NOT BE INVESTIGATED. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO RUPTURE OF THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, THE SITUATION OF THE PATIENT'S VASCULATURE LESIONS SUCH AS CALCIFICATION AND HIGHLY STENOTIC. AFTER THE BALLOON RUPTURE HAD OCCURRED, A PROCEDURE TO SECURE BLOOD FLOW WAS TAKEN BY ASSISTED VENTILATION AND STENT PLACEMENT. THE DIRECT CAUSE OF DEATH IS UNKNOWN, BUT SINCE THERE ARE NO ABNORMALITIES IN THE MANUFACTURING RECORDS, WE ASSUME THAT THE DEATH WAS CAUSED BY THE PATIENT CONDITION. IN THE INSTRUCTIONS FOR USE OF ZINRAI (3283-0) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW. [PRECAUTIONS] <IMPORTANT, BASIC PRECAUTIONS> 1. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). 8. IF ANY ABNORMALITY IS OBSERVED DURING BALLOON INFLATION, IMMEDIATELY APPLY NEGATIVE PRESSURE AND DISCONTINUE THE PROCEDURE. 12. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. <PRECAUTIONS DURING USAGE > 2. BEFORE USE, EXPEL THE AIR COMPLETELY FROM THE BALLOON AND BALLOON INFLATION LUMEN BY REPLACING IT WITH THE INFLATION MEDIUM. [IF THE AIR IS NOT COMPLETELY EXPELLED, THE INFLATION OF THE BALLOON MAY NOT BE OBSERVABLE ON FLUOROSCOPY.] 3. USE THE INFLATION MEDIUM TO INFLATE THE BALLOON. AIR OR OTHER GASES SHOULD NEVER BE USED TO INFLATE THE BALLOON. [DEVICE FAILURES AND ADVERSE EVENTS] THE USE OF THE PRODUCT MAY CAUSE THE FOLLOWING DEVICE FAILURE: 1. SEVERE DEVICE FAILURES (1) BALLOON RUPTURE 2. OTHER DEVICE FAILURES (1) LEAKAGE OF THE INFLATION MEDIUM 1. SEVERE ADVERSE EVENTS (1) DEATH.

    Description of Event or Problem · 0

    THE PATIENT HAD A HISTORY OF AORTIC VALVE STENOSIS. AT A PCI OPERATION FOR 99% OCCLUDED LEFT ANTERIOR DESCENDING AT #6, THE CONCERNED ZINRAI PTCA BALLOON WAS USED FOR PRE-DILATATION, AND BALLOON RUPTURE OCCURRED. AND AFTER THE BALLOON RUPTURE, BLOOD PRESSURE, HEART RATE, AND PULSE PRESSURE DECREASED, RESULTING IN SHOCK VITALITY. SLOW FLOW WAS CONFIRMED, AND IT WAS DETERMINED THAT THE PATIENT COULD NOT MAINTAIN HER CIRCULATORY STATUS, SO AN IABP/ECMO WAS INSERTED AND ASSISTED VENTILATION WAS INITIATED. BIOFREEDOM STENT WAS PLACED AND POST DILATATION WITH SAPPHAIRE NC WAS CONDUCTED FOR SECURING HER BLOOD FLOW. BUT THE PATIENT DIED ON THE NEXT DAY, (B)(6) 2024 BY UNKNOWN CAUSE OF DEATH. A COMMENT FROM A HEALTH PROFESSIONAL: THE PROCEDURE WAS FOR AN ELDERLY, HIGH-RISK PATIENT WITH SEVERE AORTIC STENOSIS AND SEVERE HEART FAILURE. THE BALLOON RUPTURE MIGHT HAVE CAUSED AIR EMBOLIZATION, LEADING TO WORSENING OF BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293829 KANEKA PTCA CATHETER ZINRAI ZINRAI LOX KANEKA CORPORATION SR114435

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Death