BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 6770363 · Received August 7, 2017

    Report

    Report Number
    9681834-2017-00168
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    July 15, 2017
    Report Date
    August 7, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - UDI NUMBER IS NOT REQUIRED FOR THIS PRODUCT CODE. H6 - RESULTS = 3252 IS BASED ON THE EVALUATION OF THE SAMPLE 1; 213 IS BASED ON THE EVALUATION OF THE SAMPLE 2 AND 3. H6 - CONCLUSIONS = 77 IS BASED ON THE EVALUATION OF THE SAMPLE 1; 71 IS BASED ON THE EVALUATION OF THE SAMPLE 2 AND 3. THREE (3) DEVICES, ONE OF WHICH WAS THE ACTUAL DEVICE, WERE RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE ACTUAL DEVICE, TERUMO GUIDEWIRE M (RF-GA35083 LOT#170119) WILL HEREINAFTER BE REFERRED TO SAMPLE 1, ANOTHER TERUMO GUIDEWIRE M (RF-GA25083 LOT#170116) WILL HEREINAFTER BE REFERRED TO SAMPLE 2, AND THE COMPETITOR'S SPRING GUIDEWIRE (PRODUCT/LOT# UNKNOWN) WILL HEREINAFTER BE REFERRED TO SAMPLE 3. VISUAL INSPECTION OF SAMPLE 1 FOUND THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF THE CORE WIRE ON APPROXIMATELY 120MM - 245MM FROM THE DISTAL END OF THE DEVICE, WHERE THE CORE WIRE WAS EXPOSED. VISUAL INSPECTION OF SAMPLE 2 AND 3 CONFIRMED NO ANOMALIES. MAGNIFYING INSPECTION OF SAMPLE 1 OBTAINED THE FOLLOWING FINDINGS. ON APPROXIMATELY 80MM - 280MM FROM THE DISTAL END OF THE DEVICE THE URETHANE OUTER LAYER HAD BEEN SEMI-CIRCUMFERENTIALLY SHEARED OFF THE WIRE, WITH THE EXPOSURE OF THE CORE WIRE ON APPROXIMATELY 120MM - 245MM FROM THE DISTAL END OF THE DEVICE. THE SHEAR CROSS SECTION OF THE URETHANE OUTER LAYER WAS IN THE SMOOTH STATE, IMPLYING THAT IT HAD BEEN CUT WITH A CUTTING TOOL. THERE IS A POSSIBILITY THAT THE SEMI-CIRCUMFERENTIALLY SHEARED URETHANE LAYER APPROXIMATELY 200MM IN LENGTH MAY HAVE REMAINED IN THE PATIENT'S BODY. MAGNIFYING INSPECTION OF SAMPLE 2 AND SAMPLE 3 VERIFIED THEY DID NOT HAVE ANY ANOMALIES. THE OUTSIDE DIAMETER OF SAMPLE 1 WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET MANUFACTURING SPECIFICATION. THE OUTSIDE DIAMETER OF SAMPLE 2 WAS CONFIRMED TO MEET MANUFACTURING SPECIFICATION. AS FOR SAMPLE 3, WITH NO PRODUCT RELATED TECHNICAL INFORMATION NOT UNKNOWN FURTHER INSPECTION WAS NOT CARRIED OUT ON ON SAMPLE 3. SIMULATION TESTING WAS CONDUCTED. A CURRENT GUIDEWIRE M PRODUCT SAMPLE WAS INSERTED INTO A METALLIC MATERIAL AND WITHDRAWN FROM IT. THE URETHANE COATING WAS SHEARED FROM THE PRODUCT SAMPLE. THE SHEARED CROSS SECTION SURFACE OF THE URETHANE COATING WAS CONFIRMED TO BE IN THE SMOOTH STATE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET FROM THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATIONS (RF-GA35083 LOT#170119 AND RF-GA25083 LOT#170116) WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT OF THIS NATURE WITH THE INVOLVED PRODUCT CODE /LOT NUMBER COMBINATIONS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. INVESTIGATION RESULT VERIFIED THE ACTUAL DEVICE DID NOT HAVE ANY INHERENT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE COMPLAINT DESCRIPTION, IT IS LIKELY THE ACTUAL DEVICE WAS SUBJECTED TO A WITHDRAWAL MANIPULATION IN THE STATE WHERE ITS URETHANE OUTER LAYER HAD CONTACT WITH THE INVOLVED METALLIC NEEDLE. AS THE RESULT, THE URETHANE OUTER LAYER BECAME SHEARED OFF THE WIRE. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: DO NOT MANIPULATE/WITHDRAW THE GUIDEWIRE M THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE, A METAL DILATOR OR A METAL GUIDE WIRE INSERTER 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. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A DEVICE FRAGMENT WAS LEFT IN THE PATIENT DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: TO PLACE THE CV CATHETER THE CUSTOMER USED A COMPETITOR'S SPRING GUIDEWIRE; THE CUSTOMER REPORTED IT WAS DIFFICULT TO ADVANCE THE SPRING GUIDEWIRE TO THE TARGET POSITION; THE SPRING GUIDEWIRE WAS CHANGED OUT TO THE ACTUAL SAMPLE; THE ACTUAL SAMPLE AND THE CATHETER REACHED THE TARGET POSITION; THE CUSTOMER NOTICED UNDER FLUOROSCOPICALLY THAT SOME MATERIAL PARTED FROM THE ACTUAL SAMPLE; THE CUSTOMER WITHDREW THE ACTUAL SAMPLE AND FOUND THE ACTUAL SAMPLE HAD SHEARED OFF THE OUTER URETHANE LAYER; THE SHEARED PIECE REMAINED IN A PERIPHERAL SEGMENT OF THE PULMONARY ARTERY; THE DOCTOR DETERMINED IT IMPOSSIBLE TO RETRIEVE THE PIECE; THE PROCEDURE WAS COMPLETED; THE SHEARED PIECE WAS LEFT IN THE PATIENT; AND THE PATIENT HAS NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552831 RADIFOCUS GLIDEWIRE GUIDEWIRE CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 170119

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other CV CATHETER| SPRING GUIDEWIRE| CV CATHETER| SPRING GUIDEWIRE