BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 13938005 · Received March 29, 2022

    Report

    Report Number
    9681834-2022-00047
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 29, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER: UNKNOWN. OCCUPATION: MEDICAL DIRECTOR. PMA/510(K) - K122590, K163004. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. (B)(4).

    Additional Manufacturer Narrative · 0

    ONE GUIDEWIRE ADVANTAGE (THE GUIDEWIRE) AND A PIECE OF PEELED OUTER LAYER (THE FRAGMENT) WERE RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE GUIDEWIRE OBTAINED THE FOLLOWING RESULTS: I) THE OUTER LAYER HAD BEEN PEELED AND TURNED BACK TOWARD THE DISTAL END EXPOSING THE CORE WIRE ABOUT 91 MM, IN THE AREA FROM 8 MM TO 99 MM FROM THE DISTAL END; II) THE PEELED AND TURNED-BACK PART OF THE OUTER LAYER WAS ABOUT 20 MM DUE TO HAVING BEEN STRETCHED; III) DISTAL 8 MM WAS OVERLAPPING THE DISTAL PART OF GUIDEWIRE AND 12MM WAS AHEAD FROM THE GUIDEWIRE TIP; IV) THE UNDAMAGED PART OF THE OUTER LAYER WAS ABOUT 152 MM. MAGNIFYING INSPECTION OF THE PEELED AND TURNED BACK PART OF OUTER LAYER OBTAINED THE FOLLOWING RESULTS: I) THE DISTAL END OF THE PEELED AND TURNED BACK AREA WAS IN A TORN SHAPE; II) A PART OF THE PEELED AND TURNED BACK PART HAD BEEN TAPERED; III) SOME TRACES OF ADHESION OF GOLD MARKERS WERE OBSERVED. ELECTRON MICROSCOPIC INSPECTION OF THE PEELED AND TURNED-BACK PART OF OUTER LAYER FOUND NO ABRASIONS ON THE SURFACE. UNDER THE PEELED AND TURNED-BACK PART OF OUTER LAYER, THE DISTAL END OF THE GUIDEWIRE WAS CONFIRMED INTACT UNDER X-RAY FLUOROSCOPE. MAGNIFYING INSPECTION OF THE PROXIMAL PORTION OF OUTER LAYER FOUND THAT THE DISTAL END SEEMED TO HAVE BEEN TORN OVER THE ENTIRE CIRCUMFERENCE. ELECTRON MICROSCOPIC INSPECTION OF THE END OF OUTER LAYER ON THE PROXIMAL PART OF THE GUIDEWIRE OBTAINED THE FOLLOWING RESULTS: I) CREASES WERE OBSERVED ON THE SURFACE; II) CREASES AND ABRASIONS WERE OBSERVED ON THE OTHER SIDE. ELECTRON MICROSCOPIC INSPECTION OF THE AREA NEAR THE END OF OUTER LAYER ON THE PROXIMAL PART OF THE GUIDEWIRE OBTAINED THE FOLLOWING RESULTS: I) CREASES WERE OBSERVED; II) ABRASIONS WERE OBSERVED. NO EXTERNAL ANOMALIES SUCH AS SCRATCHES OR BREAKAGE WERE OBSERVED ON THE REMAINDER PART OF THE GUIDEWIRE. THE OUTER DIAMETER WAS MEASURED ON THE NORMAL PART AND CONFIRMED TO MEET THE FACTORY'S CONTROL STANDARDS. NO ANOMALY WAS OBSERVED. THE EFFECTIVE LENGTH WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL STANDARDS. NO ANOMALY WAS OBSERVED. FROM THE INVESTIGATION RESULTS, IT WAS INFERRED THAT THERE WAS NO PORTION MISSING FROM THE GUIDEWIRE. INSPECTION OF THE FRAGMENT OBTAINED THE FOLLOWING RESULTS: I) VISUAL INSPECTION CONFIRMED IT WAS A BLACK FRAGMENT. EACH END OF THE FRAGMENT WAS REFERRED TO AS END A AND END B. THE TOTAL LENGTH WAS ABOUT 80MM. II) MAGNIFYING INSPECTION SHOWED THAT END A HAD BEEN BUCKLED END B WAS IN A TORN SHAPE. III) ELECTRON MICROSCOPIC INSPECTION FOUND RIPS ON END B. SIMULATION TEST OBTAINED THE FOLLOWING RESULTS: BASED ON THE CONDITION OF THE ACTUAL SAMPLE, IT WAS ASSUMED THAT THE REMOVAL OF THE GUIDEWIRE WAS CONTINUED WHILE IT WAS CAUGHT ON THE DISTAL END OF THE CONCURRENTLY USED BALLOON CATHETER, WHICH RESULTED IN THE PEELED AND TURNED-BACK OUTER LAYER. BASED ON THIS ASSUMPTION, A SIMULATION TEST WAS CONDUCTED ASSUMING A POSSIBILITY THAT THE GUIDEWIRE WAS CAUGHT ON THE BALLOON CATHETER DUE TO ABRASIONS ON ITS SURFACE WHEN IT WAS WITHDRAWN FROM THE BALLOON CATHETER. THE OUTER LAYER OF A TEST SAMPLE WAS ABRADED INTENTIONALLY. AS A RESULT, THE ABRADED PART WAS CAUGHT ON THE DISTAL END OF A BALLOON CATHETER. SUBSEQUENTLY, THE TEST SAMPLE WAS WITHDRAWN FROM A BALLOON CATHETER UNDER RESISTANCE, RESULTING IN THE OUTER LAYER TURNING BACK DISTALLY AND CATCHING ON THE DISTAL END OF THE BALLOON CATHETER. AT THE SAME TIME, THE CORE WIRE AND GOLD COIL WERE EXPOSED. WHEN THE TEST SAMPLE WAS WITHDRAWN FURTHER, THE OUTER LAYER WAS TORN. AS A RESULT, THE TEST SAMPLE WAS DIVIDED INTO THE MAIN BODY AND A PIECE OF PEELED OUTER LAYER. MAGNIFYING INSPECTION OF THE PEELED AND TURNED BACK PART OF THE TEST SAMPLE OBTAINED THE FOLLOWING RESULTS: I) THE DISTAL END OF THE PEELED AND TURNED BACK PART WAS IN A TORN SHAPE; II) A PART OF THE PEELED AND TURNED BACK PART HAD BEEN TAPERED; III) TRACES OF ADHESION OF GOLD MARKERS WERE OBSERVED. ELECTRON MICROSCOPIC INSPECTION OF THE PEELED AND TURNED-BACK PART OF OUTER LAYER FOUND NO ABRASIONS ON THE SURFACE. UNDER THE PEELED AND TURNED-BACK PART OF OUTER LAYER, THE DISTAL END OF THE TEST SAMPLE WAS CONFIRMED INTACT UNDER X-RAY FLUOROSCOPE. MAGNIFYING INSPECTION OF THE PROXIMAL PORTION OF OUTER LAYER FOUND THAT THE DISTAL END WAS IN A TORN SHAPE. ELECTRON MICROSCOPIC INSPECTION OF THE END OF OUTER LAYER ON THE PROXIMAL PART OF THE TEST SAMPLE OBTAINED THE FOLLOWING RESULTS: I) CREASES WERE OBSERVED ON THE SURFACE; II) ABRASIONS WERE OBSERVED ON THE SURFACE. MAGNIFYING INSPECTION OF THE PIECE OF PEELED OUTER LAYER SHOWED THAT END A WAS NOT BUCKLED, AND END B WAS IN A TORN SHAPE. ELECTRON MICROSCOPIC INSPECTION FOUND RIPS ON END B. THE ABOVE SIMULATION TEST RESULTS WERE CONSIDERED SIMILAR TO THE STATE OF THE ACTUAL SAMPLE. HOWEVER, ABRASIONS, THE STATE OF PEELED OUTER LAYER, AND THE SHAPE OF THE PEELED FRAGMENT WERE THOUGHT TO DEPEND ON THE CONCURRENTLY USED DEVICE, MANIPULATION METHOD, EXTENT OF ABRASIONS AND DEGREE OF STICKING TO A CONCURRENTLY USED DEVICE, ETC. THE PEELING OF OUTER LAYER WAS FOUND TO HAVE OCCURRED TO A GREATER EXTENT IN THE ACTUAL SAMPLE. IN THIS CASE, IT WAS THOUGHT THAT THE OUTER LAYER OF THE PROXIMAL PART OF THE ACTUAL SAMPLE WAS ABRADED BY COMING INTO CONTACT WITH SOME HARD OBJECT, AND THAT IT BECAME EASILY PEELED. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE IN THAT STATE WAS WITHDRAWN, THE PROXIMAL PART OF THE OUTER LAYER WAS TURNED BACK DISTALLY LEADING TO THE PEELING. THE SIMULATION TEST RESULT SHOWS THAT THE TEST SAMPLE WITH ABRASIONS ON THE SURFACE CAN BE CAUGHT ON THE DISTAL END OF THE CONCURRENTLY USED DEVICE WHEN SUBJECTED TO A WITHDRAWAL MANIPULATION, WHICH RESULTS IN THE PEELING OF OUTER LAYER. RELEVANT IFU REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY." "CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING AN ATTEMPT TO REVASCULARIZE THE PATIENT'S LEG VESSELS, THE DISTAL PORTION OF THE RADIFOCUS GLIDEWIRE ADVANTAGE TRACK RUPTURED INSIDE AN ANGIOPLASTY BALLOON. THE DRIVING POINT RECOVERY WAS SUCCESSFUL AND THERE WERE NO PATIENT CONSEQUENCES. THE BREAKAGE OCCURRED DURING AN ATTEMPT TO CROSS A CALCIFIC OCCLUSION OF THE ANTERIOR TIBIAL ARTERY (ATA). THERE WAS RESISTANCE DUE TO CALCIFICATIONS IN THE VESSEL LUMEN. THE BROKEN PART OF THE GUIDE REMAINED IN THE CATHETER LUMEN AND WAS REMOVED WITH A BALLOON. THE GUIDEWIRE WAS FRACTURED IN THE PATIENT'S BODY AND THE FRACTURED PIECE WAS RETRIEVED SUCCESSFULLY BY A MEDICAL INTERVENTION. DUE TO THE CALCIFIC NATURE OF THE LESIONS, THE PROCEDURE OUTCOME OF THE RECANALIZATION OF DATA FAILED. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO PATIENT DEATH, INJURY, OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898959 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 210421

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention BALLOON DILATATION CATHETER| COYOTE BOSTON SCIENTIFIC