BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIANZA PRO

    MDR report key: 18138007 · Received November 15, 2023

    Report

    Report Number
    3003775027-2023-00117
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 25, 2023
    Report Date
    July 18, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327085434
    PMA / PMN Number
    K171933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). 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. A CORSAIR PRO MICROCATHETER AND A CONFIANZA PRO GUIDE WIRE WERE RETURNED FOR EVALUATION. THE CONFIANZA PRO GUIDE WIRE WAS INSERTED IN THE CORSAIR PRO MICROCATHETER, AND THE TWO DEVICES WERE STUCK TO EACH OTHER. THE DISTAL SEGMENT OF THE CONFIANZA PRO GUIDE WIRE WAS FOUND COMING OUT OF THE TIP OF THE CORSAIR PRO MICROCATHETER FOR APPROXIMATELY 2CM. THE TIP THE CORSAIR PRO MICROCATHETER WAS FOUND INTERMITTENTLY BULGED. X-RAY OBSERVATION OF THE TIP OF THE CORSAIR PRO MICROCATHETER FOUND THAT THE OUTER COIL OF THE CONFIANZA PRO GUIDE WIRE WAS DISARRANGED AND DETACHED IN THE SHAFT PROXIMAL TO THE TIP OF THE CORSAIR PRO MICROCATHETER. HOWEVER, THE CORE WIRE OF THE CONFIANZA PRO GUIDE WIRE WAS NOT DETACHED BUT REMAINED INTACT. 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 MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE CONFIANZA PRO GUIDE WIRE WHILE ITS TIP WAS CAUGHT BY THE HEAVILY CALCIFIED CTO. CONSEQUENTLY, THE COILS OF THE GUIDE WIRE WERE DISARRANGED, INCREASING RESISTANCE BETWEEN THE GUIDE WIRE AND THE MICROCATHETER AND CAUSING THE TWO DEVICES TO GET STUCK TO EACH OTHER. AS FURTHER TORSION ACCUMULATED ON THE COIL SEGMENT OF THE CONFIANZA PRO GUIDE WIRE EXCEEDED THE PRODUCT DESIGN LIMIT, THE OUTER COIL OF THE GUIDE WIRE WAS UNRAVELED AND DETACHED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED PRODUCT QUALITY. AS THERE WERE NO SIGNIFICANT DAMAGES FOUND WITH THE CONCOMITANTLY USED CORSAIR PRO, IT WAS CONCLUDED THAT THE REPORTED DAMAGE ON THE CONFIANZA PRO GUIDE WIRE WAS NOT ATTRIBUTED TO THE CONCOMITANT MICROCATHETER. 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. - 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] - BREAKAGE OF THE GUIDE WIRE.

    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 BETWEEN THE DEVICE IDENTIFICATION FIELDS OF THE ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A THAT WE HAD SUBMITTED COMPARED TO THE INFORMATION INCLUDED FOR THE CORRESPONDING FIELDS IN THE GUDID. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT 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 AGH143090. CATALOG # - FROM AGH143090 TO NO ENTRY. G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 21-1-2022 TO NO ENTRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI CORSAIR PRO MICROCATHETER AND AN ASAHI CONFIANZA PRO GUIDE WIRE WERE USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A CHRONIC TOTAL OCCLUSION (CTO) IN THE HEAVILY CALCIFIED AND MODERATELY TORTUOUS MID LEFT CIRCUMFLEX ARTERY (LCX). AS THE CONFIANZA PRO GUIDE WIRE WAS ADVANCED, THE GUIDE WIRE GOT STUCK WITH THE CORSAIR PRO MICROCATHETER AND COULD NOT BE ADVANCED ANY FURTHER. THE TWO DEVICES WERE REMOVED TOGETHER AS A UNIT. A NEW UNIT OF CONFIANZA PRO AND A NON-ASAHI MICROCATHETER WERE USED TO CONTINUE THE PROCEDURE. IT WAS INFORMED THAT THERE WERE NO HEALTH HAZARDS ASSOCIATED WITH THE REPORTED CASE, AND THE PATIENT WAS BEING OBSERVED IN THE INTENSIVE CARE UNIT (ICU) OF THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332102 CONFIANZA PRO PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AGH143090 220105A69A 04547327085434

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female