BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION BLACK

    MDR report key: 10939799 · Received December 3, 2020

    Report

    Report Number
    3003775027-2020-00186
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 13, 2020
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K173277
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G4. EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #, H4 DEVICE MANUFACTURER DATE AND MANUFACTURING SITE BASED ON MANUFACTURING RECORDS RECEIVED ON DEC 17, 2020. MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: (B)(4). WHEN THE REPORTED DEVICE WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME, THEREFORE, THE DATE THE MANUFACTURER BECAME AWARE OF THIS EVENT WAS CONSIDERED THE DATE THE DEVICE WAS RETURNED. THE SION BLACK GUIDE WIRE WAS RETURNED FOR EVALUATION. PEELING OF THE POLYMER JACKET WAS CONFIRMED. THE PEELED POLYMER JACKET WAS GATHERED DISTALLY AND PLEATED AT APPROXIMATELY 180MM FROM THE TIP. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT, AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE METAL TIP OF THE EXCIMER LASER CATHETER HAD MOST LIKELY CONTRIBUTED TO THE OBSERVED PEELING OF THE POLYMER JACKET. THE METAL TIP WOULD CONTACT THE GUIDE WIRE LIKELY DUE TO TORTUOUS ANATOMY, SCRAPING THE POLYMER JACKET SURFACE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. ALTHOUGH THERE WERE REPORTEDLY NO ADVERSE PATIENT EFFECTS, A POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT FRAGMENT(S) OF THE POLYMER JACKET MIGHT BE LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DAMAGE ON THE POLYMER JACKET OF AN ASAHI SION BLACK GUIDE WIRE WAS OBSERVED DURING A PCI TO TREAT AN OCCLUSION IN THE TORTUOUS RCA #1. THE GUIDE WIRE WAS USED TO CROSS THE LESION. ABLATION WAS PERFORMED BY EXCIMER LASER. AN IVUS CATHETER WAS THEN DELIVERED OVER THE SION BLACK WHEN RESISTANCE WAS FELT. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT AND DAMAGE ON THE POLYMER JACKET WAS NOTED. A NEW GUIDE WIRE WAS REPLACED TO RESUME THE PROCEDURE. THE PCI WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS REPORTEDLY FINE WITHOUT PROBLEM AFTER THE PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404682 SION BLACK PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 200730A29A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other