BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAIA FIRST

    MDR report key: 16653787 · Received March 31, 2023

    Report

    Report Number
    3003775027-2023-00036
    Event Type
    Injury
    Date Received
    March 31, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K171933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. REFERRING TO KNOWN SIMILAR EVENTS, THE REPORTED LUNG INJURY (THAT IS KNOWN TO OCCUR SECONDARY TO HEMORRHAGE DUE TO PERIPHERAL VESSEL INJURY), VESSEL PERFORATION OR VESSEL DISSECTION WERE MOST LIKELY ASSOCIATED WITH PATIENT ANATOMY AND PROCEDURAL CONTEXT. NO CAPA WILL BE TAKEN. 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. 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. VESSEL DISSECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT ASAHI PRODUCTS: MIRACLEBROS 3 GUIDE WIRE, GAIA FIRST GUIDE WIRE, CORSAIR MICROCATHETER MIGHT HAVE CAUSED OR CONTRIBUTED TO SYMPTOMATIC LUNG INJURY OR PULMONARY ARTERY PERFORATION OR DISSECTION. PUBLICATION: CIRCULATION: CARDIOVASCULAR INTERVENTIONS 2021;14:E010243. DOI: 10.1161/CIRCINTERVENTIONS.120.010243 TITLE: EFFICACY AND SAFETY OF PERCUTANEOUS PULMONARY ARTERY SUBTOTAL OCCLUSION AND CHRONIC TOTAL OCCLUSION INTERVENTION IN CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION. EXCERPT: [METHODS]. ONE HUNDRED TWENTY PATIENTS UNDERWENT 712 BPA PROCEDURES BETWEEN APRIL 2014 AND OCTOBER 2019 AT THE MEDICAL UNIVERSITY OF VIENNA. CLINICAL FEATURES AND HEMODYNAMICS WERE ASSESSED AT BASELINE AND 6 TO 12 MONTHS AFTER THE LAST BPA SESSION. AFTER SELECTIVE PULMONARY ANGIOGRAPHY, A 0.014-INCH GUIDEWIRE (PILOT 50 [ABBOTT VASCULAR, SANTA CLARA, CA], MIRACLEBROS 3, OR GAIA 1 [ASAHI INTECC, TOKYO, JAPAN]) WAS PASSED CAREFULLY ACROSS THE TARGET LESION. IN CASE OF CTOS, MICROCATHETERS (FINECROSS [TERUMO CORPORATION, TOKYO, JAPAN] AND CORSAIR [ASAHI INTECC, TOKYO, JAPAN]) AND WIRES WITH HIGHER TIP LOADS (UP TO 40 G) WERE USED. CTO TECHNIQUE WAS EXECUTED IN A SIMILAR FASHION AS IN THE CORONARY ARTERIES, EXCEPT THAT SUBINTIMAL TRACKING AND RETROGRADE APPROACHES WERE NOT USED. AFTER EXAMINATION OF A PROPER GUIDEWIRE POSITION (IF NEEDED WITH DISTAL INJECTION VIA A CORSAIR MICROCATHETER) THE TARGET LESIONS WERE DILATED TO AN APPROPRIATE SIZE USING 1.25- TO 8.0-MM SEMICOMPLIANT BALLOONS (TREK AND MINI TREK [ABBOTT VASCULAR, SANTA CLARA, CA] AND IKAZUCHI [KANEKA MEDIX CORPORATION, TOKYO, JAPAN]; AVIATOR PLUS [CORDIS, BRIDGEWATER, NY]). [HEMODYNAMICS AS PREDICTORS OF PULMONARY INJURY] COMPLICATIONS OF THE OVERALL COHORT ARE SUMMARIZED IN TABLE 3. BPA-RELATED COMPLICATIONS OCCURRED IN 43 PROCEDURES (6.0% OF ALL 712 PROCEDURES) AND 30 PATIENTS (25% OF PATIENTS). PULMONARY INJURY AND HEMOPTYSIS OCCURRED IN 18 (2.5%) AND 15 PROCEDURES (2.1%), RESPECTIVELY. SEVERE PULMONARY INJURY REQUIRING MECHANICAL VENTILATION OCCURRED IN 3 PATIENTS (2.5% OF PATIENTS AND 0.4% OF PROCEDURES). TWO PATIENTS REQUIRED TRACHEAL INTUBATION AND EXTRACORPOREAL MEMBRANE OXYGENATION. ONE PATIENT COULD BE MANAGED WITH EARLY ADMINISTRATION OF SYSTEMIC CORTICOSTEROIDS AND NONINVASIVE POSITIVE PRESSURE VENTILATION. PULMONARY ARTERY PERFORATIONS AND PULMONARY ARTERY DISSECTIONS OCCURRED IN 3 PROCEDURES (0.4%). COMPLICATIONS RELATED TO VASCULAR ACCESS OCCURRED IN 3 PROCEDURES (0.4%). TABLE 3. COMPLICATIONS. PROCEDURE LEVEL (N = 180), N (%) OF PROCEDURES PATIENT LEVEL (N = 120), N (%) OF PATIENTS OVERALL COMPLICATIONS 43 (6.0) 30 (25.0), HEMOPTYSIS 15 (2.1) 13 (10.8), PULMONARY INJURY 18 (2.5) 14 (11.7), <MILD/MODERATE 15 (2.1) 11 (9.2), SEVERE 3 (0.4) 3 (2.5)>, PULMONARY ARTERY PERFORATION OR DISSECTION 3 (0.4) 3 (2.5), VASCULAR ACCESS SITE COMPLICATION 3 (0.4) 3 (2.5), INTERSTITIAL PNEUMONITIS 2 (0.3) 2 (1.7), INTUBATION 2 (0.3) 2 (1.7), EXTRACORPOREAL MEMBRANE OXYGENATION 2 (0.3) 2 (1.7), NONINVASIVE POSITIVE PRESSURE VENTILATION 1 (0.1) 1 (0.8), VAGAL REACTION 1 (0.1) 1 (0.8). MIRACLEBROS 3: MFR REPORT #: 3003775027-2023-00035. CORSAIR: MFR REPORT #: 3003775027-2023-00037.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504885 GAIA FIRST PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other