BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSLEAD PENETRATION

    MDR report key: 20948882 · Received December 17, 2024

    Report

    Report Number
    3003775027-2024-00134
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 28, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K230377
    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 CROSSLEAD PENETRATION GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE RETURNED CROSSLEAD PENETRATION GUIDE WIRE WAS FOUND WITH ITS CORE WIRE FRACTURED AT APPROXIMATELY 22MM DISTAL TO THE PROXIMAL SOLDER (SET AT 25MM FROM THE WIRE TIP). OBSERVATION OF THE CORE WIRE FRACTURE END BY MICROSCOPE AND SCANNING ELECTRON MICROSCOPE (SEM) FOUND A FLAT FRACTURE SURFACE AND HELICAL MARKS ON THE SHAFT PROXIMAL TO THE FRACTURE END, LIKELY CAUSED BY ACCUMULATED TORSION. THE FLAT FRACTURE SURFACE WAS FOUND WITH CONCENTRIC PATTERNS. MICROSCOPIC OBSERVATION OF THE PROXIMAL SOLDER FOUND THAT SOLDER MATERIAL WAS EXPOSED. THE EXPOSED SOLDER MATERIAL SURFACE HAD A TRACE OF TRANSFER MARK OF THE OUTER COIL, INDICATING THAT THE OUTER COIL WAS DETACHED FROM THE SOLDER. THESE FINDINGS SUGGESTED THAT THE CORE WIRE OF THE SUBJECT CROSSLEAD PENETRATION WAS DETACHED AT APPROXIMATELY 3MM FROM THE WIRE TIP, AND THE OUTER COIL WAS DETACHED FROM THE SOLDER. 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH ROTATIONAL WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE CROSSLEAD PENETRATION GUIDE WIRE WAS CAUGHT BY THE CALCIUM MIGHT HAVE BEEN LOCALLY ACCUMULATED TO THE DISTAL SEGMENT OF THE GUIDE WIRE. CONSEQUENTLY, THE CORE WIRE WAS FRACTURED. AS TORSIONAL STRESS WAS FURTHER ACCUMULATED, THE OUTER COIL MIGHT HAVE BEEN LOOSEN AND DETACHED FROM THE PROXIMAL SOLDER. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS CONCLUDED THAT STENTING OF THE WIRE FRAGMENT WAS CONSIDERED A WAS A REPORTABLE HEALTH HAZARD. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A 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 GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING WIRE MANIPULATIONS. ~ 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. ~ WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. [MALFUNCTIONS AND ADVERSE EVENTS] 1. MALFUNCTIONS ~ DAMAGE SUCH AS SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND 90-99% OCCLUDED LESION IN THE SEGMENT FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) TO AN UNSPECIFIED BELOW-THE-KNEE (BTK) ARTERY. WHILE AN ASAHI CROSSLEAD PENETRATION GUIDE WIRE WAS BEING USED WITH AN ASAHI CARAVEL MC MICROCATHETER, THE GUIDE WIRE GOT STUCK WITH THE CALCIUM IN THE POPLITEAL ARTERY. AFTER REMOVAL ATTEMPTS, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS FOUND DETACHED. THE WIRE FRAGMENT WAS PRESSED AGAINST THE VESSEL WALL WITH A SUPERA STENT (ABBOTT VASCULAR). THE GUIDE WIRE WAS REPLACED BY AN ASAHI GLADIUS GUIDE WIRE, AND THE LESION WAS SUCCESSFULLY CROSSED. AN UNSPECIFIED STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED "MANIPULATION TACTICS AND WIRE TIP ANGLES MAY NOT BE APPROPRIATE." IT WAS INFORMED THAT THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291307 CROSSLEAD PENETRATION PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. CLT01423P 241010A351

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Disability| R