BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCEPTOR GUIDE WIRE

    MDR report key: 37434 · Received September 6, 1996

    Report

    Report Number
    2125152-1996-00001
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    July 31, 1996
    Report Date
    September 6, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L ANALYSIS REVEALED THAT THE WIRE WAS BENT AND FRACTURED AT THE JUNCTION OF THE SPRING TIP AND CORE WIRE. THE FRACTURE WAS APPARENTLY CAUSED BY SIGNIFICANT TENSILE FORCE PLACED ON THE DEVICE. NO MATERIAL OR MANUFACTURING DEFICIENCIES WERE NOTED.

    Description of Event or Problem · 1

    DURING PTCA PROCEUDRE, THE TIP OF THE GUIDE WIRE FRACTURED AS THE BALLOON CATHETER WAS REMOVED. THE BALLOON RUPTURED PRIOR TO REMOVAL. ALL PIECES WERE RETRIEVED. PT STATUS IS LISTED AS "OK." SAME CASE AS MFR REPORT #2183819-1996-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCEPTOR GUIDE WIRE PTCA GUIDEWIRE DQX SCIMED LIFE SYSTEMS, INC. .14"SCEPTOR FL.STR D20295

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention