BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 1832232 · Received September 3, 2010

    Report

    Report Number
    3003775027-2010-00021
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 13, 2010
    Manufacturer
    SETO FACTORY OF ASAHI INTECC CO., LTD., MEDICAL DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN REC'D.

    Description of Event or Problem · 1

    DEVICE ISSUE: GUIDE WIRE PEELING. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE LESIONS WERE LOCATED IN A TOTALLY CHRONICALLY OCCLUDED DISTAL LEFT MAIN AND INTO MID TO DISTAL CIRCUMFLEX. THE ASAHI TORNUS MICRO CATHETER AND THE ASAHI GUIDE WIRE WERE SUCCESSFULLY PLACED ACROSS THE CTO LEFT MAIN. HOWEVER, UPON REMOVAL OF THE MICRO CATHETER, THERE WAS RESISTANCE BETWEEN THE TORNUS AND THE GUIDE WIRE. THEREFORE, BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. AFTER THE FIELDER GUIDE WIRE WAS REMOVED FROM THE PT, THE COATING WAS FOUND TO BE PEELING OFF OF THE GUIDE WIRE CORE. THE SAME TORNUS MICRO CATHETER WAS USED WITH A NEW ASAHI FIELDER GUIDE WIRE AND THEY CROSSED THE LEFT MAIN. AFTER THE GUIDE WIRE WAS PLACED AT THE DESIRED LOCATION, THE TORNUS MICRO CATHETER WAS REMOVED FROM THE PT WITHOUT AN ISSUE. THE LESION WAS PRE-DILATED WITH A 1.5 BALLOON. A XIENCE 2.5 X 23 AND A XIENCE 2.5 X 15 WERE BOTH ADVANCED TO THE LESION; HOWEVER, THE STENTS DID NOT CROSS. THREE ADDITIONAL XIENCE STENTS DID CROSS AND WERE DEPLOYED IN THE LEFT MAIN AND IN THE MID TO DISTAL CX. THE PROCEDURE TOOK APPROX 90 MINUTES LONGER. REPORTEDLY, THERE WERE NO PT EFFECTS. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI FIELDER XT PTCA GUIDE WIRE DQX SETO FACTORY OF ASAHI INTECC CO., LTD., MEDICAL DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR