BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSLEAD PENETRATION

    MDR report key: 21341168 · Received February 9, 2025

    Report

    Report Number
    3003775027-2025-00060
    Event Type
    Injury
    Date Received
    February 9, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 10, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327142922
    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: (B)(4). THE REPORTED CROSSLEAD PENETRATION GUIDE WIRE WAS RETURNED FOR EVALUATION. THE CORE WIRE OF THE RETURNED GUIDE WIRE WAS FOUND BENT AT APPROXIMATELY 18MM DISTAL TO THE PROXIMAL SOLDER (SET AT 25MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE WIRE) AND FRACTURED AT APPROXIMATELY 25MM FROM THE PROXIMAL SOLDER. MICROSCOPIC OBSERVATION FOUND THAT THE FRACTURE END OF THE CORE WIRE HAD A FLAT FRACTURE SURFACE AND HELICAL MARKS WERE OBSERVED ON THE CORE SHAFT NEAR THE FRACTURE END. THESE FINDINGS INDICATED THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE OBSERVED FRACTURE OF THE CORE WIRE. 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. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED AT THE DISTAL TIP, AND THE OUTER COIL WAS DETACHED TOGETHER WITH THE DISTAL 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE TIP OF THE CROSSLEAD PENETRATION GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BY THE FALSE LUMEN. 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 WIRE FRAGMENT LEFT IN PATIENT ANATOMY WAS CONSIDERED A REPORTABLE HEALTH HAZARD. NO CAPA WILL BE TAKEN. 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 100% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). WHEN AN ASAHI CROSSLEAD PENETRATION GUIDE WIRE WAS MANIPULATED WITH A COOK MEDICAL CXI SUPPORT CATHETER, WIRE CROSSING WAS DIFFICULTY DUE TO CALCIFIED LESION. THE GUIDE WIRE THEN GOT STUCK IN THE SUBINTIMAL SPACE AND WAS FRACTURED. THE WIRE FRAGMENT COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT ANATOMY. AN UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED ACROSS THE LESION THROUGH TRUE LUMEN VIA RETROGRADE APPROACH. THE PROCEDURE WAS COMPLETED WITH DRUG-COATED BALLOON (DCB) AFTER INFLATION OF AN UNSPECIFIED BALLOON CATHETER. THE PATIENT WAS REPORTEDLY FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871328 CROSSLEAD PENETRATION PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. CLP01430P 240612A451 04547327142922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability