BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION

    MDR report key: 19038871 · Received April 3, 2024

    Report

    Report Number
    3003775027-2024-00042
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 4, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327143448
    PMA / PMN Number
    K100578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 SION GUIDE WIRE WITH ITS DISTAL SEGMENT DETACHED AND THE DISTAL WIRE FRAGMENT THAT HAD ENTANGLED WITH A BENT AND CRUSHED STENT WERE RETURNED FOR INVESTIGATION. THE OUTER COIL OF THE RETURNED SION GUIDE WIRE WAS FOUND STRETCHED AND FRACTURED AT APPROXIMATELY 12MM DISTAL TO THE DISTAL MID SOLDER (SET AT 25MM FROM THE WIRE TIP). MICROSCOPIC OBSERVATION OF THE FRACTURED OUTER COIL FOUND NECKING OF THE FRACTURE END LIKELY CAUSED BY TENSILE STRESS. THE INNER COIL OF THE SION WAS FOUND EXPOSED AT APPROXIMATELY 22MM DISTAL TO THE DISTAL MID SOLDER. THE TWIST WIRE OF THE GUIDE WIRE WAS FOUND FRACTURED DISTAL TO THE TIP OF THE INNER COIL. MICROSCOPIC OBSERVATION OF THE DISTAL SEGMENT OF THE SION GUIDE WIRE ENTANGLED WITH THE STENT FOUND THAT THE OUTER COIL WAS STRETCHED FOR APPROXIMATELY 243MM FROM THE WIRE TIP AND FRACTURED, WHILE THE BALL TIP WAS FOUND ATTACHED ON THE VERY DISTAL END OF THE GUIDE WIRE. THE TWIST WIRE AND THE CORE WIRE WERE FOUND FRACTURED AT APPROXIMATELY 7MM FROM THE TIP. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND NECKING ON THE FRACTURE SURFACE OF THE OUTER COIL LIKELY CAUSED BY TENSILE STRESS. THE CORE WIRE AND THE FINE WIRES OF THE TWIST WIRE WERE FOUND TWISTED AND HAD RELATIVELY FLAT FRACTURE SURFACES, INDICATING THAT TORSIONAL STRESS HAD CONTRIBUTED TO FRACTURE. 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 TWISTING STRESS MIGHT HAVE BEEN LOCALLY ACCUMULATED DUE TO TORSIONAL WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE SION GUIDE WIRE HAD BEEN TRAPPED BY SUCH OBJECT AS A STENT STRUT, FRACTURING THE TWIST CORE AND THE CORE WIRE. AS TENSIONAL STRESS WAS APPLIED DURING WITHDRAWAL, THE OUTER COIL WAS STRETCHED AND FRACTURED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE 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. ~ 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. ~ DO NOT PERFORM STENT PLACEMENT USING MORE THAN ONE GUIDE WIRE OR WIRE OPERATION THROUGH STENT STRUT. OTHERWISE, THE STENT MAY BE DAMAGED OR THE GUIDE WIRE MAY BREAK OR BREAK APART. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SION GUIDE WIRE WAS USED TO TREAT A DISTAL SEGMENT OF THE RIGHT CORONARY ARTERY (RCA) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). AFTER A BIOFREEDOM ULTRA DRUG-COATED STENT (BIOSENSOR INTERVENSTION TECHNOLOGIES) WAS DEPLOYED TO THE TARGET LESION AND POST-DILATATION WAS PERFORMED, THE SION GUIDE WIRE WAS FOUND CAUGHT BY THE DISTAL SEGMENT OF THE STENT. ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE BUT FAILED. ALTHOUGH SUCH ADDITIONAL DEVICES AS A FINECROSS MICROCATHETER (TERUMO), AN UNSPECIFIED 0.85MM X 10MM BALLOON, AND OTHER SMALL-SIZED BALLOONS WERE ADVANCED IN PHASES, THE DISTAL SEGMENT OF THE SION GUIDE WIRE WAS FOUND DAMAGED UNDER ANGIOGRAPHY. THE FINAL ANGIOGRAPHY REVEALED THAT THE WIRE FRAGMENT WAS STUCK IN THE SEGMENT BETWEEN THE DISTAL RCA AND THE AORTIC ARCH. THE PATIENT WAS SENT FOR BYPASS SURGERY AND THE FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374367 SION PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. 230603A192 04547327143448

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Disability| R