BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTRAIL

    MDR report key: 20558574 · Received October 29, 2024

    Report

    Report Number
    9681834-2024-00188
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 29, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K113335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: HEIGHT: 5'11''. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: RISK MANAGER. AS NO ACTUAL SAMPLE WAS AVAILABLE, THE FOLLOWING INVESTIGATION WAS PERFORMED. THE INVOLVED PRODUCT CODE WAS REPORTED AS "GC-UGIL35ON"; HOWEVER, IT WAS CONFIRMED THAT THIS PRODUCT CODE DOES NOT EXIST. UPON TRACKING THE REPORTED LOT NUMBER 240202, WE FOUND THAT THE CORRESPONDING PRODUCT CODE FOR HEARTRAIL III IS 'GC-U6IL350N' EXCLUSIVELY. THEREFORE, THE INVESTIGATION WAS CONDUCTED WITH THE UNDERSTANDING THAT THE PRODUCT CODE IN QUESTION IS 'GC-U6IL350N'. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO EQUIPMENT TROUBLE WAS NOTED. NO OTHER SIMILAR ISSUES HAVE BEEN REPORTED FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. REGARDING THIS MATTER, BASED ON THE SITUATION OF OCCURRENCE, IT WAS THOUGHT TO HAVE OCCURRED THROUGH THE FOLLOWING MECHANISMS; HOWEVER, SINCE NO ACTUAL SAMPLE WAS RETURNED AND THE ANALYSIS OF IT COULD NOT BE CONDUCTED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. DURING THE PROCEDURE, EXCESSIVE BENDING STRESS WAS APPLIED TO THE CATHETER SHAFT OF THE ACTUAL SAMPLE DUE TO SOME FACTORS, CAUSING THE AFFECTED AREA TO KINK. WHEN AN ATTEMPT WAS MADE TO RESTORE THE KINK, ADDITIONAL EXTERNAL LOAD WAS APPLIED TO THE AFFECTED AREA, LEADING TO ITS FRACTURE. ASHITAKA FACTORY HAS BEEN MAKING EFFORTS IN MAINTAINING THE QUALITY OF THE PRODUCT BY PERFORMING THE FOLLOWING WORK AND INSPECTIONS. AT THE START OF THE OUTER LAYER CONNECTING PROCESS, A CONFIRMATION SAMPLE GOES THROUGH THIS PROCESS AND THEN ITS CATHETER SHAFT IS SUBJECTED TO A TENSILE STRENGTH TEST. THIS STEP ENSURES THAT THE EQUIPMENT IS FUNCTIONING PROPERLY. BEFORE THE PACKAGING PROCESS, 100% VISUAL INSPECTION OF THE CATHETER IS PERFORMED TO CONFIRM THAT THERE IS NO ANOMALY SUCH AS A KINK OR FRACTURE. IN THE PACKAGING AND CARTONING PROCESSES, DEDICATED TOOLS AND CONTAINERS ARE USED FOR HANDLING THIS PRODUCT TO PROTECT IT AND TO PREVENT IT FROM KINKING OR CRUSHING. AFTER SEALED IN THE PEEL PACK, THE PRODUCT IS KEPT IN THE STATE OF BEING HUNG UNTIL IT IS PACKED IN THE UNIT BOX SO THAT ANY UNDESIRABLE FORCE TO THE PRODUCT CAN BE AVOIDED. FOR FUTURE USE, PLEASE NOTE THE FOLLOWING POINTS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU): "[CAUTIONS FOR USE / 1. CONTRAINDICATIONS] DO NOT TORQUE THE GUIDING CATHETER EXCESSIVELY WHILE KINKED. IT MAY CAUSE DAMAGE WHICH COULD RESULT IN POSSIBLE SEPARATION ALONG THE CATHETER SHAFT." "[CAUTIONS FOR USE / 2. IMPORTANT SAFETY INSTRUCTIONS / WARNINGS] MANIPULATE THE GUIDING CATHETER SLOWLY AND CAREFULLY IN THE VESSEL. IF ANY RESISTANCE IS FELT OR IF TORQUE CANNOT BE TRANSMITTED PROPERLY TO THE CATHETER TIP, KINKING OR DISTORTION MAY OCCUR. IN SUCH CASE, STOP MANIPULATING THE GUIDING CATHETER AND DETERMINE THE CAUSE UNDER FLUOROSCOPY. MANIPULATING THE GUIDING CATHETER WITHOUT DETERMINING THE CAUSE MAY RESULT IN DAMAGE TO THE VESSEL, BREAKAGE OR SEPARATION OF THE CATHETER. THIS MAY NECESSITATE RECOVERY OF FRAGMENTS OF THE CATHETER." 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 DURING A PERCUTANEOUS CORONARY INTERVENTION, THE GUIDE CATHETER BROKE OFF IN THE BODY. INTERVENTIONAL RADIOLOGY WAS CONSULTED AND ASSISTED IN RETRIEVING THE GUIDE WITH A SNARE. NOTHING WAS RETAINED IN THE BODY. THERE WAS NO HARM TO THE PATIENT. MEDWATCH MW5159442 WAS RECEIVED ON 09OCT2024. ADDITIONAL INFORMATION WAS RECEIVED ON 10OCT2024: THE DEVICE DID NOT APPEAR TO BE DAMAGED PRIOR TO USE. DURING THE PROCEDURE THE DEVICE BECAME KINKED AND IN ATTEMPTING TO UNKINK IT AT THE TIP OF THE RADIAL SHEATH. THIS WAS REMOVED WITH A VASCULAR SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 25OCT2024: THE BREAK OCCURRED AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979039 HEARTRAIL CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA 40-6370 240202

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other| R SNARE