BEUDAMED
    FDA Adverse Event Injury Summary report: N

    .018 GLIDEWIRE ANGLED

    MDR report key: 6067 · Received July 27, 1993

    Report

    Report Number
    1219544-1993-00030
    Event Type
    Injury
    Date Received
    July 27, 1993
    Date of Event
    June 14, 1993
    Report Date
    June 25, 1993
    Manufacturer
    TERUMO
    Product Code
    MKI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR BECAME AWARE ON 6/14, 1993 OF AN INCIDENT INVOLVING A GLIDEWIRE DURING A NEPHROSTOMY PROCEDURE. THE GLIDEWIRE WAS USED THROUGH A 21 GUAGE CHIBA NEEDLE TO GAIN ENTRY. UPON REMOVAL OF THE NEEDLE THE DILATOR WAS BACKLOADED ONTO THE WIRE. UPON INJECTION OF CONTRAST THROUGH THE DILATOR IT WAS DISCOVERED THE TIP OF THE WIRE HAD BROKEN OFF IN THE PATIENT. THE PROCEDURE CONTINUED AND A DRAINAGE CATHETER WAS PLACED WITHOUT FURTHER INCIDENT. THE PHYSICIAN THE N USED HEMOSTATS ALONG SIDE THE DRAINAGE CATHETER AND SUCCEFULLY RETREIVED THE DETACHED SEGMENT. THE PATIENT DID NOT EXPERIENCE ANY SEQUELAE FROM THIS EVENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .018 GLIDEWIRE ANGLED GUIDEWIRE MKI TERUMO RFGA18153 8892J05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention