BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE GUIDWIRE

    MDR report key: 9981109 · Received April 21, 2020

    Report

    Report Number
    9681834-2020-00070
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 21, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    UDI-DI
    04953170282782
    PMA / PMN Number
    K091417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. NAME AND ADDRESS: (B)(6) HOSPITAL. HEALTH PROFESSIONAL- REQUESTED, NOT PROVIDED. POTENTIAL NOV-2019 LOT NUMBERS, AND DEVICE MANUFACTURE DATES: 191107, 07NOV2019; 191112, 12NOV2019; 191113, 13NOV2019; 191114,14NOV2019; 191123, 23NOV2019; OR 191125, 25NOV2019. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. HOWEVER, STILL IMAGES OF THE ACTUAL SAMPLE WERE PROVIDED. THEREFORE, THE INVESTIGATION WAS BASED UPON THE USER FACILITY INFORMATION AND THE IMAGES PROVIDED. THE IMAGE OF THE DISTAL SECTION OF THE ACTUAL SAMPLE SHOWED THAT THE CORE WIRE WAS PROTRUDING FROM THE OUTER LAYER (URETHANE COATING). BASED ON THIS PICTURE, IT COULD NOT BE DETERMINED WHETHER THERE WAS A MISSING PORTION OR NOT IN THE URETHANE COATING. THE URETHANE COATING OF A FACTORY-RETAINED CURRENT PRODUCT SAMPLE WAS REMOVED AND THE STATE OF THE DISTAL END OF THE CORE WIRE WAS COMPARED WITH THAT OF THE PROTRUDING CORE WIRE OF THE ACTUAL SAMPLE. IT WAS FOUND THAT THE DISTAL END OF THE CORE WIRE OF THE ACTUAL SAMPLE HAD BEEN FRACTURED AND MISSING. THE FRACTURE MODE COULD NOT BE CONFIRMED BECAUSE OF THE LOW MAGNIFICATION OF THE PROVIDED PICTURE. REPRODUCTIVE TESTING WAS PERFORMED WITH FACTORY-RETAINED CURRENT PRODUCT SAMPLES. A KINK WAS MADE ON A CATHETER, AND THEN A GUIDE WIRE WAS PUSHED WITH EXCESSIVE FORCE INTO THE CATHETER TO BE PASSED THROUGH THE KINKED SECTION WHERE THE LUMEN HAD BECOME NARROWER THAN NORMAL. AS A RESULT, NO PROTRUSION OF CORE WIRE WAS OBSERVED FROM THE URETHANE COATING. BASED ON THE ASSUMPTION THAT THE DISTAL END OF THE ACTUAL GUIDEWIRE WAS TRAPPED BY AN OBJECT, THE DISTAL END OF A GUIDEWIRE INSERTED IN A TUBE WAS TRAPPED WITH FORCEPS, AND THEN, THE GUIDE WIRE WAS PUSHED FORCEFULLY. AS A RESULT, THE DISTAL TIP BECAME DEFORMED, HOWEVER, NO PROTRUSION OF CORE WIRE WAS OBSERVED FROM THE URETHANE COATING. BASED ON THE ASSUMPTION THAT THE DISTAL END OF THE ACTUAL GUIDEWIRE WAS TRAPPED BY AN OBJECT, THE DISTAL END OF A GUIDEWIRE INSERTED IN A TUBE WAS PINCHED WITH FORCEPS, HOLD IN A CURVED SHAPE, AND THEN, THE GUIDE WIRE WAS TWISTED AND PULLED IN THE WITHDRAWAL DIRECTION. AS A RESULT, THE CORE WIRE BECAME FRACTURED, AND THEN, THE FRACTURE END PIERCED THE URETHANE COATING AND PROTRUDED DURING REMOVAL FROM THE TUBE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEETS OF ALL THE NOVEMBER 2019 LOTS WERE CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDO THERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDO THERAPY ACCESSORY. IT IS LIKELY THAT THE DISTAL SECTION OF THE ACTUAL SAMPLE WAS TRAPPED DUE TO SOME FACTORS, AND IN THAT TRAPPED STATE, THE ACTUAL SAMPLE WAS EXPOSED TO EXCESSIVE TORQUE FORCE AND PULLING FORCE; AS A RESULT, THE CORE WIRE WAS FRACTURED, AND THE FRACTURE END PIERCED THE URETHANE COATING AND PROTRUDED. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, THE ERCP GUIDEWIRE, STRAIGHT TIP -CORE OF THE GUIDEWIRE CAME THROUGH THE HYDROPHILIC COATING. IT WAS CONFIRMED THAT THE COATING DID NOT FALL OFF THE GUIDEWIRE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED. ASHITAKA RECEIVED IMAGES ON 01APR2020; VISUAL INSPECTION OF THE IMAGES DEEMED THE EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447143 SINGLE USE GUIDWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA NA UNK 04953170282782

    Patients

    Seq Age Sex Outcome Treatment
    1