BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIANZA PRO 12

    MDR report key: 18000163 · Received October 24, 2023

    Report

    Report Number
    3003775027-2023-00100
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 7, 2023
    Report Date
    July 18, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327058162
    PMA / PMN Number
    K171933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** AS WE RECEIVED AN EMAIL, TIME-STAMPED SATURDAY, JULY 6, 2024 2:09 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 AGH143391. CATALOG #: FROM AGH143391 TO NO ENTRY. G1: CONTACT OFFICE: FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE: FROM 04-3-2023 TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. A CONFIANZA PRO 12 WAS RETURNED FOR INVESTIGATION. THE TIP SEGMENT OF THE RETURNED CONFIANZA PRO 12 WAS FOUND DEFORMED IN A HOOK-LIKE SHAPE. THE GUIDE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 187MM DISTAL TO THE PROXIMAL SOLDER THAT WAS ORIGINALLY LOCATED AT 200MM FROM THE WIRE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE WIRE. MICROSCOPIC OBSERVATION OF THE FRACTURE END OF THE OUTER COIL FOUND THAT THE COIL PITCH WAS WIDENED DISTAL TO THE MID SOLDER THAT WAS ORIGINALLY LOCATED AT 15MM FROM THE WIRE TIP, AND THE OUTER COIL WAS FOUND FRACTURED TOGETHER WITH THE CORE WIRE AT APPROXIMATELY 2MM DISTAL TO THE MID SOLDER. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) OF EACH FRACTURE SURFACE FOUND THAT THE FRACTURE END OF THE CORE WIRE WAS TWISTED AND HAD A RELATIVELY FLAT FRACTURE SURFACE, INDICATING THAT THE CORE WIRE FRACTURE WAS ATTRIBUTED TO TORSION. THE FRACTURE END OF THE OUTER COIL WAS FOUND THAT THE FRACTURE END OF THE OUTER COIL WAS TWISTED, NECKED, AND HAD A RELATIVELY FLAT FRACTURE SURFACE, INDICATING THAT THE OUTER COIL FRACTURE WAS ATTRIBUTED TO TORSION AND TENSION. MEASUREMENT OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED TOGETHER WITH THE OUTER COIL AT APPROXIMATELY 13MM FROM THE WIRE TIP. 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 ACCUMULATED ON THE TIP OF THE CONFIANZA PRO 12 WHILE THE WIRE TIP WAS CAUGHT IN THE SEVERELY OCCLUDED LESION, FRACTURING THE CORE WIRE. AS FURTHER TENSION GENERATED WITH REMOVAL OF THE GUIDE WIRE WAS APPLIED, 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. 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

    USER FACILITY VOLUNTARY MEDWATCH REPORT (MDR REPORT #: MW5145569) WAS RECEIVED VIA THE US DISTRIBUTOR ON SEPTEMBER 27, 2023. IT WAS REPORTED THAT A LEGALLY BLIND AND WHEELCHAIR-BOUND PATIENT WHO HAD A HISTORY OF DIABETES MELLITUS, HYPERTENSION, AND PERIPHERAL ARTERY DISEASE UNDERWENT ANGIOGRAPHY AND PERCUTANEOUS PERIPHERAL INTERVENTION (PPI). ANGIOGRAM REVEALED SEVERE STENOSIS IN THE LEFT POPLITEAL ARTERY. ALL OF THE THREE TIBIAL VESSELS WERE OCCLUDED ON THE LEFT POSTERIOR TIBIAL ARTERY. THE PROXIMAL LEFT ANTERIOR TIBIAL ARTERY WAS PATENT, WHILE OCCLUSION WAS OBSERVED IN THE PROXIMAL POUCH. IN SPITE OF ATTEMPTS TO CROSS THE ANTERIOR TIBIAL ARTERY WITH AN ASAHI CONFIANZA PRO 12 GUIDE WIRE, IT COULD BE ADVANCED AS FAR AS THE DISTAL SEGMENT OF THE LESION. AT THIS POINT, THE PHYSICIAN DETERMINED TO PRESERVE THE POSTERIOR TIBIAL ARTERY FOR FUTURE USE AS A BYPASS GRAFT. AN UNSPECIFIED 3MM X 120MM BALLOON WAS DILATED FOR INSUFFICIENT 2 MINUTES OR MORE TO PERFORM BALLOON ANGIOPLASTY TO THE PROXIMAL SEGMENT OF THE ANTERIOR TIBIAL ARTERY AND THE OVERALL POPLITEAL ARTERY, WHICH IMPROVED THE BLOOD FLOW IN THE TIBIAL ARTERY. THE DISTAL SEGMENT OF THE CONFIANZA PRO 12 WAS FOUND FRACTURED AND LEFT IN THE PATIENT ANATOMY AFTER REMOVAL FROM THE DISTAL SEGMENT OF THE POPLITEAL ARTERY. THE PHYSICIAN CONCLUDED THAT THE SITE WHERE THE GUIDE WIRE GOT FRACTURED WOULD NOT CAUSE ANY HARMS TO THE PATIENT AND DETERMINED TO LEAVE THE FRAGMENT IN SITU. AS ANGIOGRAM REVEALED THAT THE OCCLUSIONS IN THE POPLITEAL ARTERY AND THE PROXIMAL ANTERIOR TIBIAL ARTERY WERE RESOLVED, AND THE BLOOD FLOW WAS SIGNIFICANTLY IMPROVED BY WAY OF A WIDE RANGE OF COLLATERAL CHANNELS THAT HAD BEEN DEVELOPED TO PROVIDE BLOOD FLOW TO THE FOOT, THE PROCEDURE WAS TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847667 CONFIANZA PRO 12 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AGH143391 230227A231 04547327058162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability