BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI MIRACLE BROS PTCA GUIDE WIRE

    MDR report key: 1396469 · Received May 29, 2009

    Report

    Report Number
    3003775027-2009-00015
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: GUIDE WIRE TIP SEPARATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: GUIDE WIRE TIP SEPARATION. IT WAS REPORTED THAT DURING A LEFT RENAL ARTERY STENTING PROCEDURE, USING A BRACHIAL APPROACH, THREE GUIDE WIRES FROM ANOTHER COMPANY WOULD NOT CROSS. THE PHYSICIAN ATTEMPTED AN ASAHI MIRACLE BROS GUIDE WIRE AND MET RESISTANCE AND WAS NOT ABLE TO ADVANCE THE GUIDE WIRE ANY FURTHER. THE PHYSICIAN ATTEMPTED TO PULL THE GUIDE WIRE OUT WHEN APPROXIMATELY 3 CM OF THE GUIDE WIRE TIP SNAPPED OFF WITHIN THE AORTA. A SNARE DEVICE WAS USED TO REMOVE THE GUIDE WIRE TIP SUCCESSFULLY. THERE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, DISTRIBUTOR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI MIRACLE BROS PTCA GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 081215A551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention