BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEON PTCA BALLOON DILATATION CATHETER

    MDR report key: 17629039 · Received August 27, 2023

    Report

    Report Number
    3002808904-2023-00004
    Event Type
    Injury
    Date Received
    August 27, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 1, 2023
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "NEON", 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 DISCARDED AND NOT RETURNED FOR DEVICE EVALUATION. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO LEAKAGE INCLUDE, BUT ARE NOT LIMITED TO, DURING PREPARATION OF THE CATHETER OR INSERTING IT INTO THE GUIDING CATHETER ALONG A GUIDEWIRE, SUDDEN DEFORMATION OR PERFORATION TO THE CATHETER SHAFT WAS OCCURRED WHICH LEADS TO LEAKAGE. THE PATIENT CONDITION OF A TRANSIENT CARDIOPULMONARY ARREST BY GAS EMBOLISM MIGHT LEAD TO BE OCCURRED DUE TO THE OPERATION WHILE WITHDRAWAL AND/OR PATIENT CONDITION. IN THE INSTRUCTIONS FOR USE OF NEON (3229-3) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS DURING USAGE]. [IMPORTANT BASIC PRECAUTIONS]. 1. THIS CATHETER MAY BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. 7. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). 8. SINCE SERIOUS COMPLICATIONS MIGHT ARISE WHEN USING THIS CATHETER, OPERATION SHOULD BE DONE IN THE MEDICAL INSTITUTION WHERE EMERGENCY PROCEDURE CAN BE EXECUTED. [ADVERSE EVENTS]: ADVERSE EVENTS RELATED TO THE PRODUCT INCLUDE, BUT ARE NOT LIMITED TO, INFARCTION CAUSED BY OCCLUSION OF DISTAL VESSELS OR SIDE BRANCH, VASOSPASM, STRIPPING OF VASCULAR ENDOTHELIUM, DISSECTION OF VASCULAR INTIMA, RE-OCCLUSION, VASCULAR PERFORATION OR RUPTURE, UNSTABLE ANGINA, BLOOD PRESSURE FLUCTUATION, STROKE, SHOCK, REACTION TO DRUGS, REACTION TO CONTRAST MEDIA, RENAL INSUFFICIENCY, TRANSIENT ISCHEMIA, AIR EMBOLISM, THROMBOEMBOLISM, INTERNAL BLEEDING, HEMATOMA, INFECTION, ETC. THESE ADVERSE EVENTS MAY CAUSE EMERGENT CORONARY BYPASS SURGERY, MYOCARDIAL INFARCTION, RE-STENOSIS, CARDIAC TAMPONADE, HEMORRHAGE, EMERGENT BRAIN SURGERY FOR CEREBRAL INFARCTION, FORMATION OF VESSEL FISTULA, ANEURYSM, ARRHYTHMIA, AND EVEN DEATH.

    Description of Event or Problem · 0

    WHEN THE BALLOON WAS POSITIONED ON ITS TARGET IN THE LEFT CORONARY ARTERY, IT WAS IMPOSSIBLE TO INFLATE PROPERLY. THE BALLOON WAS TAKEN OUT TO BE CHECKED, BUT AT THAT MOMENT THE PATIENT HAD A TRANSIENT CARDIOPULMONARY ARREST BY GAS EMBOLISM. SHE WAS IMPROVED ON ADRENALINE AND LARYNGEAL MASK VENTILATION AND TRANSFERRED TO INTENSIVE CARE. THE BALLOON WAS THEN CHECKED: WHILE INFLATING, LIQUID ESCAPED AT THE LEVEL OF THE RAPID EXCHANGE ORIFICE OF THE GUIDE. AFTER RECOVERY FROM A TRANSIENT CARDIOPULMONARY ARREST BY GAS EMBOLISM BY ADRENALINE AND LARYNGEAL MASK VENTILATION, THE PROCEDURE WAS CONTINUED WITH GOOD RESULTS. THE PATIENT RECEIVED 3 ACTIVE STENTS (FIREHAWK): 2.5X16 ON LEFT CORONARY ARTERY. 2.5X13 AND 3X8 IN THE RIGHT CORONARY (S2 SEGMENT TILL OSTIUM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317213 NEON PTCA BALLOON DILATATION CATHETER NEON LOX KANEKA CORPORATION SR023302

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other