BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SASUKE

    MDR report key: 21370527 · Received February 12, 2025

    Report

    Report Number
    3003775027-2025-00062
    Event Type
    Injury
    Date Received
    February 12, 2025
    Report Date
    March 10, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327120197
    PMA / PMN Number
    K182844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE HAD NOT BEEN RETURNED YET. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND REVIEWING THE KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT TENSION AND/OR TORSION GENERATED WITH MANIPULATION OF THE CONCOMITANTLY USED GUIDE WIRE MIGHT HAVE BEEN APPLIED TO THE SUBJECT ASAHI SASUKE DOUBLE-LUMEN CATHETER WHILE ITS DISTAL SEGMENT HAD BEEN CAUGHT DUE TO ANATOMICAL AND LESION CONDITIONS. CONSEQUENTLY, THE TIP SEGMENT WAS DETACHED. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT STENTING THE WIRE FRAGMENT WAS CONSIDERED A HEALTH HAZARD. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] 6) DO NOT ADVANCE THIS CATHETER THROUGH A HEAVILY CALCIFIED LESION. DOING SO MAY DAMAGE THIS CATHETER OR A BLOOD VESSEL. HEAVILY CALCIFIED LESION MEANS RADIOPACITIES NOTED WITHOUT CARDIAC MOTION BEFORE CONTRAST INJECTION GENERALLY COMPROMISING BOTH SIDES OF THE ARTERIAL LUMEN. MODERATE CALCIFIED LESION MEANS RADIOPACITIES NOTED ONLY DURING THE CARDIAC CYCLE BEFORE CONTRAST INJECTION. [PRECAUTIONS] 9) DURING USE, ALWAYS CHECK AND MONITOR THE MOVEMENT OF THE DISTAL END OF THE CATHETER UNDER HIGH-RESOLUTION FLUOROSCOPY. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THE CATHETER INTO OR FROM STENOTIC AREAS AND VESSELS NARROWER THAN THE CATHETER. DURING PCI, CHECK IF THE LUMEN OF THE PRODUCT IS NOT OBSTRUCTED. [MALFUNCTION AND ADVERSE EFFECTS] 1) MALFUNCTION SEPARATION DEBRIS FROM A DAMAGED CATHETER.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THE REPORTED SASUKE MICROCATHETER WAS RETURNED FOR INVESTIGATION. THE TIP SEGMENT AND THE MARKER OF THE RETURNED SASUKE MICROCATHETER WERE FOUND DETACHED. A PART OF THE TIP TUBE WAS FOUND REMAINED ON THE SHAFT TUBE. THE DETACHED EDGES OF THE TIP TUBE AND THE SHAFT TUBE HAD TRACES OF POLYMER DUCTILE FRACTURE LIKELY CAUSED BY TENSION. THE TIP FRAGMENT WAS NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSION GENERATED WITH MANIPULATION OF THE SUBJECT SASUKE MICROCATHETER AND/OR THE CONCOMITANTLY USED GUIDE WIRE MIGHT HAVE BEEN APPLIED TO THE SUBJECT SASUKE MICROCATHETER WHILE ITS DISTAL SEGMENT HAD BEEN CAUGHT DUE TO ANATOMICAL AND LESION CONDITIONS. CONSEQUENTLY, THE TIP SEGMENT WAS DETACHED. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT STENTING THE WIRE FRAGMENT WAS CONSIDERED A HEALTH HAZARD. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS]: 6) DO NOT ADVANCE THIS CATHETER THROUGH A HEAVILY CALCIFIED LESION. DOING SO MAY DAMAGE THIS CATHETER OR A BLOOD VESSEL. HEAVILY CALCIFIED LESION MEANS RADIOPACITIES NOTED WITHOUT CARDIAC MOTION BEFORE CONTRAST INJECTION GENERALLY COMPROMISING BOTH SIDES OF THE ARTERIAL LUMEN. MODERATE CALCIFIED LESION MEANS RADIOPACITIES NOTED ONLY DURING THE CARDIAC CYCLE BEFORE CONTRAST INJECTION. [PRECAUTIONS]: 9) DURING USE, ALWAYS CHECK AND MONITOR THE MOVEMENT OF THE DISTAL END OF THE CATHETER UNDER HIGH-RESOLUTION FLUOROSCOPY. PARTICULAR ATTENTION SHOULD BE PAID WHEN INSERTING OR WITHDRAWING THE CATHETER INTO OR FROM STENOTIC AREAS AND VESSELS NARROWER THAN THE CATHETER. DURING PCI, CHECK IF THE LUMEN OF THE PRODUCT IS NOT OBSTRUCTED. [MALFUNCTION AND ADVERSE EFFECTS]: 1) MALFUNCTION: SEPARATION. DEBRIS FROM A DAMAGED CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH AN ASAHI SASUKE DOUBLE LUMEN CATHETER TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED BIFURCATION LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING MANIPULATION OF AN UNSPECIFIED GUIDE WIRE AT THE BIFURCATION SEGMENT, THE TIP SEGMENT OF THE SUBJECT SASUKE DOUBLE LUMEN CATHETER WAS CAUGHT AND DETACHED. THE WIRE FRAGMENT WAS LEFT IN THE RCA, WHICH WAS STENTED BY AN UNSPECIFIED STENT. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042715 ASAHI SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. SA145-33N 240702F041 04547327120197

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Disability| R