BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 21645142 · Received March 19, 2025

    Report

    Report Number
    9681834-2025-00047
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 19, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: DR. (B)(6). E1: PHONE NUMBER: REQUESTED, NOT PROVIDED. G4: 510(K): NO: K063372, 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 HISTORICAL INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE AND LOT NUMBER WAS CONDUCTED. NO ANOMALIES WERE FOUND IN THE MANUFACTURING RECORD OR THE SHIPPING INSPECTION RECORD. ADDITIONALLY, NO OTHER SIMILAR REPORTS WERE FOUND IN THE PAST. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5, TO UPDATE SECTION D9 AND SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL AND MICROSCOPIC INSPECTIONS REVEALED THAT THE DISTAL END WAS FRACTURED. A TORN SHAPE WAS OBSERVED AT THE FRACTURED SECTION OF THE OUTER LAYER. THE OUTER LAYER WAS TWISTED APPROXIMATELY 18MM FROM THE FRACTURED SECTION AND INTERMITTENTLY ABRADED FROM APPROXIMATELY 20MM TO 192MM FROM THE FRACTURED SECTION. NO ANOMALIES WERE FOUND IN OTHER SECTIONS. MICROSCOPIC INSPECTION OF THE GOLD COIL AND WIRE AT THE FRACTURED SECTION REVEALED THAT THE OUTER LAYER OF THE ACTUAL DEVICE WAS REMOVED TO EXPOSE THE GOLD COIL AND WIRE. PART OF THE GOLD COIL WAS ELONGATED, BUT THE WIRE REMAINED UNEXPOSED FROM THE GOLD COIL. ELECTRON MICROSCOPIC INSPECTION OF THE WIRE REVEALED THAT THE WIRE WAS EXPOSED FROM THE GOLD COIL. ONE SIDE OF THE FRACTURED SECTION OF THE WIRE WAS FLAT, WHILE THE OTHER SIDE WAS TWISTED. SPIRAL PATTERNS ORIGINATING FROM THE CENTER AND DIMPLE (HOLE-SHAPED) PATTERNS WERE OBSERVED ON THE TOP SURFACE OF THE FRACTURED SECTION OF THE WIRE. CONFIRMATION OF THE OUTER DIAMETERS OF THE HYDROPHILIC AND PTFE COATINGS AT THE NORMAL SECTIONS MET THE FACTORY'S SPECIFICATIONS. NO ANOMALIES WERE FOUND. CONFIRMATION OF THE MISSING LENGTH OF THE ACTUAL DEVICE FROM THE DISTAL END OF THE GOLD COIL TO THE FRACTURED SECTION OF THE WIRE WAS APPROXIMATELY 0.5MM. THE PRODUCT WITH THE INVOLVED PRODUCT CODE HAD A LENGTH OF APPROXIMATELY 0.5MM FROM THE DISTAL END OF THE OUTER LAYER TO THE DISTAL END OF THE GOLD COIL. COMPARED TO THE PRODUCT WITH THE INVOLVED PRODUCT CODE, IT WAS INFERRED THAT THE MISSING LENGTH OF THE WIRE WAS APPROXIMATELY 1MM. SINCE THE OUTER LAYER WAS FRACTURED AT THE END OF THE GOLD COIL, IT WAS INFERRED THAT THE MISSING LENGTH OF THE OUTER LAYER WAS APPROXIMATELY 0.5MM. SIMULATION TESTS WERE CONDUCTED TO EVALUATE THE FRACTURE DUE TO TORQUE FORCE AND THE APPLICATION OF PULLING FORCE AFTER THE WIRE WAS FRACTURED. IN THE FIRST TEST, CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION WHILE THE DISTAL END WAS STUCK. THE RESULT SHOWED THAT ONE SIDE OF THE WIRE WAS FLATTENED WHILE THE OTHER SIDE WAS TWISTED, WITH SPIRAL PATTERNS ORIGINATING FROM THE CENTER AND DIMPLE (HOLE-SHAPED) PATTERNS OBSERVED ON THE TOP SURFACE OF THE WIRE. IN THE SECOND TEST, THE WIRE WAS INITIALLY FRACTURED, AND PULLING FORCE WAS THEN APPLIED TO FRACTURE THE DISTAL END OF THE OUTER LAYER. FURTHER PULLING FORCE WAS APPLIED IN THIS STATE, CAUSING THE WIRE TO COME OUT OF THE GOLD COIL. A TORN SHAPE WAS OBSERVED AT THE FRACTURED SECTION OF THE OUTER LAYER. AFTER REMOVING THE OUTER LAYER, THE GOLD COIL WAS FOUND TO BE ELONGATED, WITH THE WIRE REMAINING UNEXPOSED FROM THE GOLD COIL, RESEMBLING THE STATE OF DAMAGE IN THE ACTUAL DEVICE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND DIMENSIONS OF THE NORMAL SECTION. AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING MECHANISMS WERE INFERRED. HOWEVER, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF STUCK. THE DISTAL END OF ACTUAL DEVICE GOT STUCK FOR SOME FACTOR. SINCE CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION IN THAT STATE, THE WIRE WAS FRACTURED. THE REMOVAL OPERATION WAS THEN PERFORMED, PULLING FORCE WAS APPLIED, AND THE OUTER LAYER FRACTURED ALONG WITH THE FRACTURED WIRE. REGARDING THE CAUSE OF ABRASION, IT WAS INFERRED THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH SOME HARD OBJECT. HOWEVER, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 THE TIP BROKE OFF. A PHYSICIAN WAS PERFORMING A RECANALIZATION OF THE POPLITEAL ARTERY. THIS WAS A VERY CALCIFIED LESION, LEVEL P2/P3, AROUND 8 CM LONG. DURING RECANALIZATION, THE PROXIMAL PART OF THE TIP OF THE WIRE CAME LOOSE, AROUND 1 CM LONG. THIS REMAINS STUCK IN THE LESION. NO EFFORT WAS MADE TO RETRIEVE THIS PART OF THE WIRE. IT STAYS IN PLACE AND DIDN'T MOVE UNDER FLUOROSCOPY. THE WIRE WAS CHANGED TO A NEW ONE WHICH SUCCESSFULLY CROSSED THE LESION. AFTER THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED, A STENT (SUPERA) WAS PLACED WITH GOOD RESULT. THE STENT COVERED THE TIP OF THE WIRE THAT REMAINED BEHIND. AT THE LEVEL OF THE TIP, THE STENT WAS MORE PACKED. SERIOUS INJURY BECAUSE IT IS BROKEN IN THE BODY AND LEFT BEHIND. IT IS BROKEN IN THE BODY AND LEFT BEHIND.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE IS BROKEN INSIDE THE BODY BUT HAS NOT CAUSED ANY HARM AND REMAINS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545645 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM 240829A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention