BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTATO XS 40

    MDR report key: 16595871 · Received March 23, 2023

    Report

    Report Number
    3003775027-2023-00031
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 23, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131278
    PMA / PMN Number
    K163426
    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 HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). THE ASTATO 40 GUIDE WIRE WAS RETURNED FOR EVALUATION. TIP SEPARATION WAS CONFIRMED ON THE RETURNED GUIDE WIRE. THE COIL WAS FOUND FRACTURED AT THE MID SOLDER THAT WAS ORIGINALLY LOCATED AT 15MM FROM THE TIP. THE EXPOSED CORE WAS FOUND FRACTURED AT APPROXIMATELY 12.5MM FROM THE MID SOLDER. THE FRACTURE SURFACE OF THE COIL WAS FLAT, INDICATING THAT TORSION GENERATED WHEN THE COIL WAS PULLED AND STRAIGHTENED HAD CAUSED THE COIL TO FRACTURE. OBSERVATION BY SCANNING ELECTRON MICROSCOPE REVEALED THAT THE FRACTURE SURFACE OF THE CORE WAS FLAT AND SHOWED CONCENTRIC DIMPLE PATTERN. THESE FINDINGS INDICATED THAT TORSION HAD CAUSED THE CORE TO FRACTURE. MEASUREMENT ON THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WAS FIRST FRACTURED AT APPROXIMATELY 2.5MM FROM THE TIP AND THEN THE COIL FRACTURED AT 15MM FROM THE TIP, DETACHING THE TIP COMPLETELY FROM THE REST. 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 WIRE MANIPULATION HAD MOST LIKELY CONTRIBUTED TO THE OBSERVED SEPARATION OF THE CORE. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE COIL TO ELONGATE AND EVENTUALLY FRACTURED TO DETACH THE TIP. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. 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. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF AN ASAHI ASTATO 40 GUIDE WIRE HAD SEPARATED DURING AN ENDOVASCULAR THERAPY TO TREAT A HEAVILY CALCIFIED OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. WHEN TORSION WAS APPLIED ON THE GUIDE WIRE THAT WAS TRAPPED BY THE EXISTING STENT, THE WIRE TIP BECAME DETACHED. THE SEPARATED TIP WAS STENTED TO THE VESSEL WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENTING. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. IT WAS REPORTED THAT THE TIP OF AN ASAHI ASTATO 40 GUIDE WIRE HAD SEPARATED DURING AN ENDOVASCULAR THERAPY TO TREAT A HEAVILY CALCIFIED OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. WHEN TORSION WAS APPLIED ON THE GUIDE WIRE THAT WAS TRAPPED BY THE EXISTING STENT, THE WIRE TIP BECAME DETACHED. THE SEPARATED TIP WAS STENTED TO THE VESSEL WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENTING. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420102 ASTATO XS 40 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 220618A37A 04547327131278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| S