BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIANZA PRO 12

    MDR report key: 19474496 · Received June 6, 2024

    Report

    Report Number
    3003775027-2024-00060
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131261
    PMA / PMN Number
    K171933
    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: 3009121749. THE REPORTED ASTATO XS 9-12/ CONFIANZA PRO 12 GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE SEPARATED WIRE TIP. THE OUTER COIL WAS FOUND STRETCHED FROM THE MID SOLDER (SET AT 13MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE WIRE) AND THEN FRACTURED TOGETHER WITH THE CORE WIRE AT APPROXIMATELY 7MM DISTAL TO THE MID SOLDER. THE BALL TIP WAS FOUND ATTACHED ON THE VERY DISTAL END OF THE SEPARATED TIP FRAGMENT. ORIGINATING FROM APPROXIMATELY 5MM PROXIMAL TO THE TIP, THE OUTER COIL WAS STRETCHED FOR 38MM AND THEN FRACTURED. THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 6MM FROM THE TIP. OBSERVATION BY MICROSCOPE AND SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE FRACTURE ENDS OF THE OUTER COIL WAS NECKED AND THE SHAFT OF THE OUTER COIL WAS TWISTED NEAR THE FRACTURE ENDS. THESE FINDINGS INDICATED THAT THE OUTER COIL FRACTURE WAS ATTRIBUTED TO TORSION AND TENSILE STRESS GENERATED MOST LIKELY WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. THE CORE FRACTURE ENDS HAD A PATTERN OF CONCENTRIC CIRCLES ON THE RELATIVELY FLAT FRACTURE SURFACE AND THE CORE SHAFT WAS TWISTED NEAR THE FRACTURE ENDS, INDICATING THAT TORSION HAD CONTRIBUTED TO THE CORE WIRE FRACTURE. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE OUTER COIL WAS STRETCHED AND FRACTURED AT APPROXIMATELY 8.8 MM FROM THE TIP AND THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 6MM FROM THE TIP. MEASUREMENT OF THE RETURNED GUIDE WIRE CONFIRMED THAT THE ENTIRE GUIDE WIRE WAS RETURNED. 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 TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY APPLIED ON THE CORE WIRE OF THE GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BY THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE CORE WIRE WAS FRACTURED. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE OUTER COIL STRETCH TO FRACTURE. 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 BETWEEN THIS GUIDE WIRE AND THE OTHER INTERVENTIONAL DEVICES WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL, AVOID APPLYING EXCESSIVE FORCE. WHEN ABNORMAL RESISTANCE IS FELT, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S BODY AND DETERMINE THE CAUSE. OTHERWISE, THE GUIDE WIRE MAY BREAK OR BE DAMAGED AND MAY CAUSE INJURY TO THE BLOOD VESSEL OR LEAVE FRAGMENTS 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 A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE BELOW-THE-KNEE AREA. WHEN AN ASAHI ASTATO XS 9-12 (DISTRIBUTED AS CONFIANZA PRO 12 IN THE US) GUIDE WIRE WAS INSERTED TO CROSS THE LESION, IT GOT TRAPPED AT THE ENTRANCE OF THE LESION. DURING WIRE REMOVAL, THE COIL WAS STRETCHED AND THE WIRE TIP GOT SEPARATED. AFTER REMOVAL OF THE WIRE FRAGMENT THAT WAS REMAINED INSIDE THE GUIDE CATHETER, A GUIDE WIRE WITH HIGH TIP LOAD WAS USED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECTS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862803 CONFIANZA PRO 12 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 231211A03A 04547327131261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown