BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SASUKE

    MDR report key: 19486571 · Received June 7, 2024

    Report

    Report Number
    3003775027-2024-00061
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327108553
    PMA / PMN Number
    K182844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THE REPORTED SASUKE MICROCATHETER WAS RETURNED FOR EVALUATION. TIP SEPARATION WAS CONFIRMED ON THE RETURNED MICROCATHETER. PROXIMAL TO THE TORN END OF THE CATHETER TIP, THE SHAFT TUBE WAS FOUND CRUSHED AND STRETCHED. TRACES OF DUCTILE TEARING BY TENSILE STRESS WERE OBSERVED ON THE SHAFT POLYMER AT THE TORN END. WHEN COMPARED WITH AN UNUSED SASUKE MICROCATHETER, THE TIP OF THE SUBJECT SASUKE MICROCATHETER WAS FOUND TORN OFF AT APPROXIMATELY 4MM FROM THE TIP. 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 THE ABOVE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSILE STRESS GENERATED WITH CATHETER REMOVAL MIGHT HAVE BEEN LOCALLY APPLIED ON THE TIP OF THE SASUKE MICROCATHETER WHILE THE CATHETER TIP WAS TRAPPED BY THE CONCOMITANT KUSABI SHORT THAT WAS USED FOR CATHETER REMOVAL. CONSEQUENTLY, THE CATHETER TIP WAS TORN OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [PRECAUTIONS] ~ THIS PRODUCT MUST BE MANIPULATED WHILE CHECKING THIS PRODUCT'S MOTION UNDER HIGH-RESOLUTION X-RAY FLUOROSCOPY. IN ADDITION, IF ANY RESISTANCE IS FELT DURING THE MANIPULATION OF THIS PRODUCT, INTERRUPT THE MANIPULATION, AND CHECK THE CAUSE UNDER HIGH-RESOLUTION X-RAY FLUOROSCOPY. [MALFUNCTIONS AND ADVERSE EFFECTS] ~ SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE SECOND DIAGONAL BRANCH (D2). AN ASAHI SASUKE MICROCATHETER WAS ADVANCED OVER AN ASAHI MINAMO GUIDE WIRE AND USED FOR THE SIDE BRANCH. DURING REMOVAL OF THE SASUKE USING A KANEKA MEDIX KUSABI SHORT EXCHANGE CATHETER INSIDE THE GUIDE CATHETER, SLIGHT RESISTANCE WAS FELT. ANGIOGRAPHY REVEALED DETACHED TIP OF THE SASUKE MICROCATHETER IN DISTAL D2. TIP SEPARATION WAS CONFIRMED ON THE REMOVED SASUKE MICROCATHETER. ATTEMPTS WERE MADE TO RETRIEVE THE CATHETER FRAGMENT BY SNARING AND TWISTING WIRE TECHNIQUE, BUT WERE UNSUCCESSFUL. GIVEN THAT THE FRAGMENT WAS IN THE DISTAL D2, THE PHYSICIAN DECIDED TO LEAVE IT SITU AND FOLLOW UP THE PATIENT. THE PROCEDURE WAS THEN RESUMED AND WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW ACHIEVED BY STENTING. THE PATIENT WAS REPORTEDLY FINE WITHOUT PROBLEM AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424092 SASUKE PERCUTANEOUS CATHETER DQY ASAHI INTECC CO., LTD. NA 230109F011 04547327108553

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| S