BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 16453765 · Received February 28, 2023

    Report

    Report Number
    9681834-2023-00034
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    December 29, 2022
    Report Date
    February 28, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    UDI-DI
    04987350779373
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. DATE OF BIRTH: REQUESTED, NOT PROVIDED. WEIGHT: REQUESTED, NOT PROVIDED. ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION: RISK MANAGER. INVESTIGATION FINDINGS: CODE 114 IS BASED UPON THE COMPLAINT DESCRIPTION AND PAST SIMULATION TEST; CODE 3221 IS BASED UPON THE DEVICE NOT RETURNED. AS NO ACTUAL SAMPLE WAS AVAILABLE, THE FOLLOWING INVESTIGATION WAS PERFORMED. OF THE PRODUCTS SHIPPED TO THE US, ONLY TW*AS418XA WAS APPLICABLE TO THE LOT (220610). THEREFORE, IT WAS AWARE THAT TW*AS418XA WAS THE INVOLVED PRODUCT CODE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER, NO ANOMALY WAS FOUND. OF THE PAST COMPLAINT FILE OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER, NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. BASED ON OUR PAST KNOWLEDGE, WE HAVE BEEN AWARE THAT WIRE IS FRACTURED WHEN FOLLOWING FORCE IS APPLIED. USING A FACTORY-RETAINED RUNTHROUGH NS, THE DISTAL END OF COIL WAS TRAPPED, AND FOLLOWING FORCEA WERE APPLIED RESPECTIVELY. IN EACH CASE, THE NITI CORE WIRE INSIDE THE PLATINUM COIL WAS FRACTURED. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED SECTION OF EACH NITI CORE WIRE OBTAINED FOLLOWING RESULTS. WHEN PULLING FORCE WAS APPLIED: THE FRACTURED SECTION WAS TAPERED, THE FRACTURE SURFACE WAS DIAGONAL, AND A DIMPLE PATTERN (A HOLE-SHAPED PATTERN) WAS FOUND. WHEN REPEATED BENDING FORCE WAS APPLIED: THE FRACTURED SECTION WAS CURVED, AND A DIMPLE PATTERN WAS FOUND ON THE FRACTURE SURFACE. WHEN PULLING FORCE WAS APPLIED IN A LOOPED STATE: IT WAS FOUND THAT THE FRACTURED SECTION WAS CURVED AND TAPERED. IN ADDITION, THE FRACTURE SURFACE WAS TWISTED. WHEN TORQUE FORCE WAS APPLIED: IT WAS FOUND THAT THE FRACTURED SECTION WAS TWISTED. WHEN THE REMOVAL OPERATION IS PERFORMED UNDER THESE CIRCUMSTANCES, THE PLATINUM COIL FRAYED AND ELONGATED. FURTHERMORE, IT WAS FOUND THAT THE PLATINUM COIL FRACTURED IF THE REMOVAL OPERATION WAS CONTINUED. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF THIS COMPLAINT, THE FOLLOWING FACTOR WAS INFERRED. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. THE DISTAL END OF ACTUAL COIL WAS TRAPPED DUE TO SOME FACTOR (E.G. STENOSIS LESION). SINCE ONE OF THE FORCES WAS APPLIED, THE NITI CORE WIRE INSIDE THE PLATINUM COIL WAS FRACTURED. SUBSEQUENTLY, REMOVAL OPERATION WAS PERFORMED. AS A RESULT, THE PLATINUM COIL WAS FRAYED AND ELONGATED. AS THE REMOVAL OPERATION WAS CONTINUED, THE PLATINUM COIL WAS FRACTURED. ASHITAKA FACTORY IS ALWAYS MAKING EFFORTS TO MAINTAIN THE PRODUCT QUALITY BY PERFORMING FOLLOWING CONTROLS. AFTER THE COIL/NITI-CORE WIRE FIXING PROCESS, 100% VISUAL INSPECTION IS PERFORMED. IN THE PRODUCT ASSEMBLING PROCESS, THE OUTER DIAMETER IS MEASURED ON 100% BASIS. IN THE MANUFACTURING PROCESS, PULLING STRENGTH TEST IS PERFORMED ON 100% BASIS. IN THE SHIPPING INSPECTION, PULLING STRENGTH IS MEASURED ON SAMPLING BASIS PER PRODUCT CODE/LOT. PLEASE KEEP IN MIND THE FOLLOWING WARNING IN INSTRUCTIONS FOR USE (IFU) WHEN USING THIS PRODUCT IN THE FUTURE: "IF ANY RESISTANCE TO THE RUNTHROUGH NS OR THE DILATATION CATHETER IS FELT DURING MANIPULATION OR IF THE SHAPE, BEHAVIOUR OR POSITION OF THE GUIDE WIRE'S TIP SEEMS IMPROPER, E.G. IN A CASE WHERE THE TIP IS[?]TRAPPED DUE TO VESSEL SPASM OR SOME OTHER CAUSE OR THE TIP IS FOLDED STOP MANIPULATING THE GUIDE WIRE (AND THE CATHETER) AND DETERMINE THE CAUSE CAREFULLY BY FLUOROSCOPY AND TAKE SUITABLE REMEDIAL ACTIONS. THEN REMOVE THE GUIDE WIRE SLOWLY, WITHOUT TURNING, TO EXCHANGE IT FOR A NEW ONE. CONTINUING GUIDE WIRE OR CATHETER[?]MANIPULATION IN THE SAID SITUATIONS MAY RESULT IN DAMAGE TO THE VESSEL, DAMAGE TO OR SEPARATION OF THE GUIDE WIRE'S TIP, AND/OR DAMAGE TO THE DILATATION CATHETER." PLEASE SEE MDR 2243441-2023-00009 FOR THE IMPORTER REPORT. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE MAUDE REPORT. TERUMO TMC PERFORMED A MAUDE SEARCH ON 31 MAR 2023. REPORT NUMBER (B)(4) WAS FOUND AND WAS CONFIRMED TO BE THE SAME REPORTED EVENT; THEREFORE, THE MAUDE REPORT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 2 TO CORRECT SECTION D3.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 2301650000-2023-8001. THE EVENT DESCRIPTION STATES: "AS THE PHYSICIAN ATTEMPTED TO PULL THE INTERVENTIONAL WIRE FROM THE LEFT CORONARY ARTERY, THE WIRE TIP FRACTURED INSIDE THE LEFT ANTERIOR DESCENDING ARTERY, MULTIPLE ATTEMPTS TO RETRIEVE THE FRACTURED PART FAILED. PATIENT WAS STABLE, DENIES CHEST PAIN OR SHORTNESS OR BREATH, HAD A TIMI FLOW 3, BP150/94, HR 92 AND SINUS." NO BLOOD LOSS WAS REPORTED. THERE WAS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE TYPE OF INTERVENTION USED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561097 RUNTHROUGH NS WIRE, GUIDE, CATHETER, DQX TERUMO CORPORATION, ASHITAKA N/A 220610 04987350779373

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| O