BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 16098935 · Received January 4, 2023

    Report

    Report Number
    9681834-2022-00268
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    November 17, 2022
    Report Date
    January 4, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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. G4: PMA/510(K) - K122590, K163004. INSPECTION OF THE RETURNED SAMPLES: THE RETURNED SAMPLES UPON RECEIPT WERE ONE GUIDEWIRE ADVANTAGE (THE ACTUAL SAMPLE) AND ONE BALLOON CATHETER FROM ANOTHER MANUFACTURER. VISUAL AND MAGNIFYING INSPECTIONS OF THE ACTUAL SAMPLE FOUND THAT; THE OUTER LAYER HAD BEEN PEELED OFF AND THE CORE WIRE WAS EXPOSED IN THE AREA APPROXIMATELY 114 MM - 195 MM FROM THE DISTAL END (APPROXIMATELY 81 MM IN LENGTH). THE FRACTURED POINT OF OUTER LAYER WAS LOCATED AT APPROXIMATELY 102 MM AND AT 195 MM FROM THE DISTAL END. THE OUTER LAYER WAS TURNED BACK AT APPROXIMATELY114 MM FROM THE DISTAL END. IT WAS OBSERVED THAT THE OUTER LAYER OF THE AREA APPROXIMATELY 102 MM - 114 MM FROM THE DISTAL END WAS TURNED BACK IN THE DISTAL DIRECTION, OVERLAPPING FOR APPROXIMATELY 12 MM. THERE WERE NO OTHER EXTERNAL ANOMALIES SUCH AS SCRATCHES OR PEELING OF THE OUTER LAYER IN OTHER SITES. FROM THE ABOVE MEASUREMENT RESULTS, IT WAS CONFIRMED THAT THE OUTER LAYER OF APPROXIMATELY 69 MM IN LENGTH WAS MISSING FROM THE ACTUAL SAMPLE. EXPOSED LENGTH OF CORE WIRE (APPROXIMATELY 81 MM) - OVERLAPPING LENGTH OF OUTER LAYER (APPROXIMATELY 12 MM) = APPROXIMATELY 69 MM. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND THAT; THERE WAS A LONGITUDINAL SCRATCH AT APPROXIMATELY 30 MM FROM THE DISTAL END. THERE WAS A CONTACT MARK WITH SOME KIND OF HARD OBJECT AT APPROXIMATELY 50 MM FROM THE DISTAL END. THE FRACTURE END AT APPROXIMATELY 102 MM AND AT APPROXIMATELY 195 MM FROM THE DISTAL END WERE IN A TORN-OFF SHAPE. FROM THIS, IT WAS CONSIDERED THAT THE ACTUAL SAMPLE HAD BEEN EXPOSED TO SOME HARD OBJECT IN THE LONGITUDINAL DIRECTION. THE OVERALL LENGTH AND THE OUTER DIAMETER OF THE UNDAMAGED PART OF ACTUAL SAMPLE WERE WITHIN OUR CONTROL STANDARDS. NO ANOMALY WAS OBSERVED. VISUAL AND MAGNIFYING INSPECTIONS OF THE BALLOON CATHETER FOUND; NO ANOMALY IN THE APPEARANCE SUCH AS BENDING, A BLACK OBJECT INSIDE THE DISTAL TIP, AND NO EXTERNAL ANOMALIES SUCH AS SCRATCHES ON OTHER PARTS. 6.X-RAY FLUOROSCOPIC INSPECTION OF THE BALLOON CATHETER FOUND THAT THE BLACK OBJECT INSIDE THE DISTAL TIP HAD RADIOPAQUE PROPERTY. THE BLACK OBJECT WAS REMOVED FROM THE CATHETER AND INSPECTED VISUALLY WITH A MICROSCOPE. TWO PIECES OF BLACK OBJECT WERE CONFIRMED. THEY WERE IN CYLINDRICAL AND SHREDDED SHAPE, AND THE LENGTH WAS 9.6 MM AND 3.1 MM. THE BLACK SUBSTANCES WERE SUBJECTED TO FT-IR ANALYSIS AND FOUND TO HAVE IR-SPECTRUM VERY SIMILAR TO THAT OF THE OUTER LAYER OF THE DISTAL END OF THE ACTUAL SAMPLE. FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY): AN ANALYSIS METHOD THAT IRRADIATES SUBSTANCES WITH INFRARED LIGHT AND MEASURES THE TRANSMITTED OR REFLECTED LIGHT FOR STRUCTURAL ANALYSIS AND QUANTITATIVE ANALYSIS. FROM THE INVESTIGATION RESULTS 6, 7, AND 8, IT WAS CONSIDERED THAT THE BLACK OBJECT THAT HAD LOCATED INSIDE THE BALLOON CATHETER WAS THE OUTER LAYER THAT HAD SEPARATED FROM THE ACTUAL SAMPLE. FROM THIS, IT WAS CALCULATED THAT THE OUTER LAYER OF APPROXIMATELY 56.3 MM WAS MISSING FROM THE ACTUAL SAMPLE. DEFECT LENGTH OF OUTER LAYER (APPROXIMATELY 69 MM) - BLACK OBJECT INSIDE BALLOON CATHETER (APPROXIMATELY 9.6 MM + 3.1 MM) = APPROXIMATELY 56.3 MM. RECORD REVIEW: REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY IN THEM. REVIEW OF THE COMPLAINT FILE FOUND NO SIMILAR INDICATIONS FOR THE INVOLVED PRODUCT CODE/LOT. SIMULATION TEST: FROM THE CONDITION OF THE ACTUAL SAMPLE, IT WAS PRESUMED THAT THE DISTAL END OF THE CONCURRENTLY USED BALLOON CATHETER WAS CAUGHT IN A SCRATCH IN THE OUTER LAYER OF THE ACTUAL SAMPLE, AND DUE TO CONTINUED INSERTION OF THE BALLOON CATHETER, THE OUTER LAYER OF THE ACTUAL SAMPLE WAS TURNED BACK AND FRACTURED. BASED ON THE ASSUMPTION FROM THE DESCRIPTION OF THE EVENT THAT THE ACTUAL SAMPLE WAS SCRATCHED WHEN COMBINED WITH A METAL NEEDLE, THE FOLLOWING SIMULATION WAS PERFORMED. A FACTORY-RETAINED BALLOON CATHETER FOR THE EXTREMITY VASCULAR MODEL WAS USED FOR THIS SIMULATION TEST. WHEN A GUIDEWIRE WAS COMBINED WITH A METAL NEEDLE, THE OUTER LAYER WAS EXPOSED TO THE METAL NEEDLE AND SCRATCHED. WHEN THE BALLOON CATHETER WAS INSERTED, ITS DISTAL TIP WAS CAUGHT IN THE SCRATCH OF THE OUTER LAYER. WHEN THE INSERTION OF THE BALLOON CATHETER IN THAT CAUGHT STATE WAS CONTINUED, THE OUTER LAYER OF THE GUIDEWIRE WAS TURNED BACK IN THE DISTAL DIRECTION AND FRACTURED. THE TURNED BACK OUTER LAYER FILLED THE CLEARANCE BETWEEN THE BALLOON CATHETER AND THE GUIDEWIRE ADVANTAGE, CAUSING THE GUIDEWIRE TO STICK TO THE BALLOON CATHETER. WHEN THE GUIDEWIRE WAS WITHDRAWN, THE TURNED BACK OUTER LAYER WAS SEPARATED FROM THE GUIDEWIRE AND REMAINED INSIDE THE BALLOON CATHETER. MAGNIFYING INSPECTION OF THE TESTED GUIDEWIRE SAMPLE FOUND THAT; THE OUTER LAYER WAS PEELED OFF AND THE CORE WIRE WAS EXPOSED. THE OUTER LAYER WAS FRACTURED AND TURNED BACK IN THE DISTAL DIRECTION IN THE OUTER LAYER PEELED OFF AREA. THE PIECE OF PEELED OUTER LAYER REMAINED INSIDE THE DISTAL TIP OF BALLOON CATHETER. THE CONDITION OF THE TESTED SAMPLE APPEARED TO BE SIMILAR TO THE CONDITION OF THE ACTUAL SAMPLE. BASED ON THE CONDITION OF THE ACTUAL SAMPLE, THE FOLLOWING MECHANISM WAS INFERRED TO HAVE CAUSED THE PROBLEM. THE OUTER LAYER OF THE ACTUAL SAMPLE WAS SCRATCHED WHEN USED IN COMBINATION WITH A METAL NEEDLE. WHEN THE BALLOON CATHETER WAS INSERTED OVER THE ACTUAL SAMPLE, ITS DISTAL TIP WAS CAUGHT ON THE SCRATCH, CAUSING THE OUTER LAYER OF THE ACTUAL SAMPLE TO TURN BACK. CONTINUED INSERTION OF THE BALLOON CATHETER PROGRESSED THE TURNING BACK OF THE OUTER LAYER, AND THE OUTER WAS FRACTURED. THE TURNED BACK OUTER LAYER FILLED THE CLEARANCE BETWEEN THE BALLOON CATHETER AND THE GUIDEWIRE, WHICH RESULTED IN THE STICKING OF GUIDEWIRE THAT WAS POINTED OUT. WHEN THE GUIDEWIRE WAS REMOVED, SOME PART OF THE TURNED BACK AND FRACTURED OUTER LAYER REMAINED IN THE BALLOON CATHETER. IT WAS CONSIDERED THAT THE OUTER LAYER OF APPROXIMATELY 56.3 MM WAS MISSING FROM THE ACTUAL SAMPLE. IFU STATES: "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE ADVANTAGE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAW THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEY HAD A TRANSPEDAL PUNCTURE WITH A STEEL NEEDLE FROM COOK, THEN INSERTION OF THE GWA 18/300. NEEDLE WAS REMOVED AND A PASSEO 18 WAS INSERTED OVER THE WIRE WHICH GOT COMPLETELY STUCK ON THE GWA 18. SO BOTH PRODUCTS HAD TO BE REMOVED TOGETHER. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199694 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 220414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PASSEO 18| STEELE NEEDLE FROM COOK