BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 4161897 · Received October 10, 2014

    Report

    Report Number
    9681834-2014-00254
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 10, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED ON THE DISTAL SEGMENT. THE SEPARATED DISTAL PIECE WAS NOT RETURNED FOR EVALUATION. THE TOTAL LENGTH MEASURED (B)(4) MM, WHICH INDICATES THAT THE FRACTURE OCCURRED ON THE SHAFT AT APPROXIMATELY (B)(4) MM FROM THE DISTAL END. MAGNIFYING INSPECTION OF THE FRACTURE FOUND THE CORE WIRE WAS EXPOSED ON THE DISTAL EXTREMITY. MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE GENERATION OF SOME CREASES ON THE SURFACE OF THE URETHANE LAYER. THESE CREASES ARE KNOWN TO APPEAR ON THE SURFACE OF THE URETHANE LAYER AS A RESULT OF THE URETHANE LAYER HAVING BEEN ONCE STRETCHED BY A PULLING FORCE AND THEN GETTING SHRUNK. SUBSEQUENTLY, THE FRACTURE CROSS SECTION WAS ALSO INSPECTED UNDER MICROSCOPE AND REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN PARTIALLY STRETCHED OUT. THE URETHANE LAYER WAS REMOVED FOR FURTHER ELECTRON MICROSCOPIC INSPECTION OF THE STATE OF THE FRACTURE. ON THE LATERAL SIDE OF THE FRACTURE, THERE WAS NOT ANY ANOMALY. THE FRACTURE CROSS-SECTION SURFACE HAD BECOME ROUGH WITH THE GENERATION OF THE DIMPLE PATTERN ON IT. FUNCTIONAL TESTING CONFIRMED ALL PERFORMANCE SPECIFICATIONS WERE MET. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE BENDING FORCES AT A 90- DEGREE ANGLE TILL IT GOT FRACTURED. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THAT THE CROSS SECTION SURFACE WAS IN THE ROUGH STATE, WITH THE GENERATION OF A DIMPLE PATTERN, VERY SIMILAR TO THAT OF THE ACTUAL SAMPLE WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY AND SHIPPING INSPECTION RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS PRODUCT CODE LOT NUMBER COMBINATION. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE INVOLVED SAMPLE IS MOST CONSISTENT WITH THE ACTUAL BEING SUBJECTED TO REPETITIVE BENDING FORCE DURING INSERTION INTO THE CALCIFIED LESION. AS THE RESULT, THE CORE WIRE GOT FRACTURED DUE TO METAL FATIGUE AND SUBSEQUENT PULLING FORCE LED THE URETHANE LAYER GETTING RIPPED OFF. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY"; AND "IF ANY RESISTANCE IS FELT, OR IF THE TIPS BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PTA/STENT ILIAC'S PROCEDURE THE WIRE BECAME UNATTACHED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING: THE LEFT ILIAC WAS OCCLUDED AND HEAVILY CALCIFIED; WHILE ATTEMPTING TO CROSS, THE DISTAL TIP OF THE WIRE APPROX 5CM BECAME UNATTACHED; THE WIRE TIP WAS STENTED IN PLACE; ILIACS WERE STENTED; THE PROCEDURE WAS COMPLETED; AND THE OUTCOME WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644066 RADIFOCUS GLIDEWIRE GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 140226

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other