BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUCISE RP 35, ACU-PACK

    MDR report key: 335748 · Received May 31, 2001

    Report

    Report Number
    2027111-2001-00019
    Event Type
    Other
    Date Received
    May 31, 2001
    Date of Event
    April 18, 2001
    Report Date
    May 31, 2001
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED AFTER THE PLACEMENT OF THE STENT DURING AN ACUCISE PROCEDURE. THE DECISION WAS MADE TO LEAVE THE GUIDEWIRE IN THE PATIENT SO THAT THE STENT WOULD NOT BE DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25127 ACUCISE RP 35, ACU-PACK ACUCISE CATHETER KOD APPLIED MEDICAL RESOURCES B1005 01A397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other