BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTATO XS 9-12

    MDR report key: 18361991 · Received December 20, 2023

    Report

    Report Number
    3003775027-2023-00132
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 24, 2023
    Report Date
    July 19, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327181268
    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

    UDI RELATED DATA QUALITY UPDATES ONLY. AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, JULY 6, 2024 1:27 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A WHEN COMPARED WITH THE INFORMATION IN THE GUDID. THE SUBJECT DEVICE WAS INITIALLY REPORTED AS ASTATO XS 9-12 WHICH IS DISTRIBUTED AS CONFIANZA PRO 12 IN THE US; THEREFORE, BRAND NAME IN BLOCK D1 WAS CHANGED FROM CONFIANZA PRO 12 TO ASTATO XS 9-12 AS INDICATED IN THE PACKAGE LABEL OF THE SUBJECT DEVICE. ALTHOUGH CONFIANZA PRO 12 IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD OUTSIDE THE US UNDER THE BRAND NAME ASTATO XS 9-12. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF CONFIANZA PRO 12 IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO PAGH143091R. CATALOG # - FROM PAGH143091R TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 07-3-2023 TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749 WHEN THE REPORTED PRODUCT WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, G3. DATE RECEIVED BY MANUFACTURER IS THE SAME AS THE DATE IN D9. RETURNED TO MANUFACTURER. THE REPORTED ASTATO XS 9-12/ CONFIANZA PRO 12 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE TIP OF THE RETURNED GUIDE WIRE WAS FOUND SLIGHTLY WAVY. DISTAL TO THE MID SOLDER OF THE GUIDE WIRE (SET AT 15MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE), THE OUTER COIL WAS LOOSENED AND FRACTURED. THE FRACTURED OUTER COIL WAS FOUND GATHERED DISTALLY, EXPOSING THE UNDERLYING CORE. THE FRACTURE ENDS OF THE OUTER COIL HAD RELATIVELY FLAT FRACTURE SURFACES, INDICATING TORSION GENERATED AS THE COIL LOOSENED HAD CAUSED COIL 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 THE TORSION GENERATED WITH TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE TIP OF THE GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BY THE HEAVILY STENOSED LESION. CONSEQUENTLY, THE COIL COULD BE LOOSENED AT THE MID SOLDER WHERE THE OUTER COIL WAS FIXED, AND EVENTUALLY FRACTURED. 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] ~ BREAKAGE 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 90-99% STENOSIS IN THE BELOW-THE-KNEE AREA. WHEN ATTEMPTS WERE MADE TO CROSS THE LESION WITH AN ASAHI ASTATO XS 9-12 (DISTRIBUTED AS CONFIANZA PRO 12 IN THE US) GUIDE WIRE, DIFFICULTY WAS MET. AFTER REMOVAL OF THE ASTATO XS 9-12 GUIDE WIRE, NECKING WAS OBSERVED ON THE GUIDE WIRE. THE GUIDE WIRE WAS THEN REPLACED TO RESUME THE PROCEDURE. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109574 ASTATO XS 9-12 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. PAGH143091R 230222A32A 04547327181268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown