BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI FIELDER FC

    MDR report key: 6878229 · Received September 20, 2017

    Report

    Report Number
    3003775027-2017-00162
    Event Type
    Injury
    Date Received
    September 20, 2017
    Report Date
    September 20, 2017
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. COMPLAINT LIST WAS REVIEWED TO IDENTIFY IF THE REPORTED CASE HAD BEEN REPORTED; HOWEVER, IT COULD NOT BE DETERMINED WITH LIMITED INFORMATION. IT WAS CONCLUDED THAT THE REPORTED DATA WAS TOO OLD TO OBTAIN FURTHER INFORMATION. IN DISCUSSION, THE ARTICLE MENTIONED THAT COMPARING TO THE SUCCESSFUL CTO-PCI GROUP TO THE FAILED CTO-PCI GROUP, FAILED GROUP DEMONSTRATED SIGNIFICANT DIFFERENCES THAT IT HAD HIGHER RATE OF HAVING LESION CALCIFICATION, LESION TORTUOSITY, OR IN-STENT STENOSIS, LONGER PROCEDURE TIME AND LONGER FLUOROSCOPY EXPOSURE. IT WAS INFERRED THAT THE PATIENT CONDITION AND/OR OPERATOR'S TECHNIQUE MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE PATIENT EFFECTS. ALTHOUGH THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW COULD NOT BE CONDUCTED, SINCE ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. INSTRUCTIONS FOR USE STATES: - [WARNINGS] WHEN THIS MICROCATHETER IS PLACED IN VESSEL, ALWAYS MANIPULATE IT WITH CARE BY CONFIRMING THE POSITION OF DISTAL END OF MICROCATHETER UNDER FLUOROSCOPY. SURFACE OF THIS MICROCATHETER IS PROVIDED WITH HYDROPHILIC COATING FOR LUBRICITY, THIS MICROCATHETER MAY HAPPEN TO BE ADVANCED TOO FAR TOWARD PERIPHERY OVER THE TARGET AREA OF THE OPERATOR'S AIM. (THE BLOOD VESSEL AND/OR THE MICROCATHETER MAY BE DAMAGED.); AND, - [MALFUNCTIONS AND ADVERSE EVENTS] DAMAGE TO VESSEL INCLUDING VESSEL DISSECTION, VESSEL PERFORATION AND VESSEL RUPTURE.

    Description of Event or Problem · 1

    ACCORDING TO A REGISTRY STUDY REPORT TITLED "INDEPENDENT PREDICTORS OF RETROGRADE FAILURE IN CTO-PCI AFTER SUCCESSFUL COLLATERAL CHANNEL CROSSING" IN THE CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (90:E11-E18 (2017)), 1,656 RETROGRADE CTO-PCI WERE PERFORMED IN 45 JAPANESE FACILITIES FROM JANUARY 2009 TO DECEMBER 2012. OF THOSE, 1,276 PROCEDURES, WHERE GUIDE WIRE/MICROCATHETER WAS ABLE TO CROSS A COLLATERAL CHANNEL, WERE STUDIED FOR EVALUATING PREDICTING FACTORS OF CTO-PCI FAILURE. OF THOSE, MACCE OCCURRED IN 1.45% (BREAKDOWN: CARDIAC DEATH: 0.24%; NONCARDIAC DEATH: 0.24%; EMERGENT CABG: 0.12%; QMI: 0.24%; NON-QMI: 0.42%; CEREBROVASCULAR EVENTS: 0.18%). REPORTEDLY, COLLATERAL CHANNEL INJURY OCCURRED IN 211 CASES AND COLLATERAL CHANNEL PERFORATION REQUIRING HEMOSTASIS OCCURRED IN 45 CASES (2.7%). THE MULTIPLE DEVICES WERE USED IN THIS STUDY BUT NO INFORMATION WAS AVAILABLE REGARDING WHAT DEVICE CAUSED OR CONTRIBUTED TO WHAT COMPLICATION. IT WAS CONCLUDED THAT A POSSIBILITYCOULD NOT BE COMPLETELY RULED OUT THAT AN ASAHI DEVICE(S) MIGHT HAVE CAUSED OR CONTRIBUTED TO THOSE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659122 ASAHI FIELDER FC PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention