BEUDAMED
    FDA Adverse Event Death Summary report: N

    SION BLUE

    MDR report key: 18638070 · Received February 5, 2024

    Report

    Report Number
    3003775027-2024-00012
    Event Type
    Death
    Date Received
    February 5, 2024
    Report Date
    February 5, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K191464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. MULTIPLE ASAHI PRODUCTS WERE USED IN THIS STUDY; HOWEVER, HOW EACH MENTIONED PRODUCT HAD CAUSED OR CONTRIBUTED TO MACE WAS UNABLE TO BE DETERMINED BASED ON THE LIMITED WRITTEN INFORMATION. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND PROCEDURAL CONTENTS WERE MOST LIKELY ASSOCIATED WITH ADVERSE EVENTS OCCURRED DURING THIS STUDY. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ~ USE THIS GUIDE WIRE CAREFULLY AS THE GUIDE WIRE MAY PENETRATE THE BLOOD VESSEL. OTHERWISE, IT MAY CAUSE ADVERSE EVENTS SUCH AS BLOOD VESSEL PERFORATION AND CORONARY ARTERY DISSECTION. THE HIGHER TORQUE PERFORMANCE, STIFFER DISTAL END, AND/OR HIGHER ADVANCEMENT FORCE MAY PRESENT A HIGHER RISK OF PERFORATION OR INJURY THAN IF USING A MORE FLEXIBLE GUIDE WIRE. THEREFORE, USE THE MOST FLEXIBLE GUIDE WIRE THAT WILL TREAT THE LESION (I.E., THE GUIDE WIRE WITH THE SMALLEST TIP LOAD THAT WILL TREAT THE LESION), AND TAKE DUE CARE TO MINIMIZE THE RISK OF PERFORATION OR OTHER DAMAGE TO BLOOD VESSELS. [MALFUNCTION AND ADVERSE EFFECTS] ~ DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION. ~ CARDIAC TAMPONADE DUE TO VESSEL PERFORATION. ~ THROMBUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT ASAHI SION BLUE GUIDE WIRE MIGHT HAVE CAUSED OR CONTRIBUTED TO MACE. PUBLICATION: INT HEART J 2023; 64: 352-357. TITLE: COMPARISON OF PERCUTANEOUS CORONARY INTERVENTION PROCEDURES AND OUTCOMES FOR RECENT AND ACUTE ST-ELEVATION MYOCARDIAL INFARCTION. EXCERPTS: [SUMMARY] THIS IS A RETROSPECTIVE AND SINGLE-CENTER STUDY OF 903 CONSECUTIVE PATIENTS WITH ACUTE CORONARY SYNDROMES (ACS). AMONG THE 903 PATIENTS, 250 WERE TREATED WITH PCI FOR TYPE I STEMI WITH A TOTALLY OCCLUDED IRA. ACCORDING TO THE TIME BETWEEN SYMPTOM ONSET AND DIAGNOSIS, PATIENTS WERE DIVIDED INTO THE RECENT-STEMI (N = 32) AND ACUTE-STEMI (N = 218) GROUPS. THE BACKGROUND, PROCEDURE DETAILS, AND SHORT-TERM OUTCOMES WERE ANALYZED. NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS WERE NOTED REGARDING PATIENT DEMOGRAPHICS, ACUTE MYOCARDIAL INFARCTION SEVERITY, OR IRA DISTRIBUTION. THE IN-HOSPITAL MORTALITY RATES WERE 0% AND 4.6% IN THE RECENT-STEMI AND ACUTE-STEMI GROUPS, RESPECTIVELY (P > 0.05). [METHODS] STUDY DESIGN: RETROSPECTIVE REVIEW WAS PERFORMED HOSPITAL RECORDS, WHICH REVEALED THAT 903 CONSECUTIVE PATIENTS WITH ACUTE CORONARY SYNDROMES (ACS), INCLUDING STEMI, NON-STEMI, AND UNSTABLE ANGINA, HAD BEEN ADMITTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CCU) AT THE NIPPON MEDICAL SCHOOL HOSPITAL BETWEEN JANUARY 2015 AND DECEMBER 2018. AMONG THESE ACS PATIENTS, 250 TYPE I STEMI PATIENTS7) WITH TOTALLY OCCLUDED IRA WHO HAD BEEN TREATED WITH PCI WERE SELECTED FOR ANALYSIS IN THE PRESENT STUDY. THE PARTICIPANTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TIME OF SYMPTOM ONSET TO DIAGNOSIS AND AS PER THE GUIDELINES OF THE JAPANESE CIRCULATION SOCIETY: RECENT STEMI (N = 32), DIAGNOSED MORE THAN 24 HOURS FOLLOWING SYMPTOM ONSET WITH TOTAL OCCLUSION OF THE IRA CONFIRMED BY CORONARY ANGIOGRAPHY (CAG) AND WITH MANIFESTATIONS RESULTING FROM MYOCARDIAL ISCHEMIA; AND ACUTE STEMI (N =218), DIAGNOSED WITHIN 24 HOURS FOLLOWING SYMPTOM ONSET. DIAGNOSIS AND TREATMENT OF STEMI: PCI WAS PERFORMED AT THE DISCRETION OF THE OPERATOR USING A STANDARD TECHNIQUE. DURING THE STUDY PERIOD, WE COULD USE THE FOLLOWING FLOPPY WIRE: SION (ASAHI INTECC), SION BLUE (ASAHI INTECC), RUNTHROUGH NS FLOPPY (TERUMO), AND RUNTHROUGH NS HYPERCOAT (TERUMO). IN THIS STUDY, GUIDEWIRES USED FOR SIDE BRANCH PROTECTION WERE EXCLUDED, AND ONLY THOSE USED TO PASS THE OCCLUDED LESIONS WERE INCLUDED IN THE ANALYSIS. PROCEDURE-RELATED COMPLICATIONS WERE DEFINED AS IN-HOSPITAL DEATH, MI OR ISCHEMIC STROKE ASSOCIATED WITH PCI PROCEDURES, CARDIAC TAMPONADE, CORONARY PERFORATION, HEART FAILURE, OR CARDIOGENIC SHOCK REQUIRING CIRCULATORY ASSISTIVE DEVICES OR INOTROPIC AGENTS, STENT THROMBOSIS, EMERGENCY SURGERY, AND BLEEDING COMPLICATIONS REQUIRING BLOOD TRANSFUSION. [RESULTS] ANGIOGRAPHIC AND CLINICAL OUTCOMES: THE FREQUENCY OF PROCEDURE-RELATED COMPLICATIONS DURING PCI WAS EXTREMELY LOW IN BOTH GROUPS (3.1% VERSUS 0%, P = 0.128). THE IN-HOSPITAL MORTALITY RATES WERE 0% AND 4.6% IN THE RECENT-STEMI AND ACUTE-STEMI GROUPS, RESPECTIVELY, WITH NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS (P = 0.37). [CONCLUSIONS] THIS STUDY REVEALED THAT PCI'S SAFETY AND SUCCESS RATE WERE COMPARABLE TO THOSE OF PATIENTS WITH ACUTE-STEMI, INCLUDING IN-HOSPITAL MORTALITY OF PATIENTS WITH RECENT-STEMI WITH TOTALLY OCCLUDED IRA. ALTHOUGH, RECENT-STEMI CASES REQUIRED MORE COMPLICATED PCI TECHNIQUES THAN ACUTE-STEMI CASES. TABLE II. CORONARY ANGIOGRAPHIC FINDINGS AND DETAILS OF PCI. RECENT STEMI (N = 32). COMPLICATION...1 (3.1%). IN-HOSPITAL DEATH...0 (0%). ACUTE STEMI (N=218). COMPLICATION... 0 (0%). IN-HOSPITAL DEATH...10 (4.5%). COMPLICATION...0.128. IN-HOSPITAL DEATH...0.37. SION: MFR REPORT #3003775027-2024-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348190 SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O| R| L