BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT CATHETER

    MDR report key: 9144857 · Received October 2, 2019

    Report

    Report Number
    9681834-2019-00168
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 6, 2019
    Report Date
    October 2, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED FOR THE REPORTED PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K) - K033913. (B)(4). THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION AND WAS REPORTED TO BE INFECTIOUS; THEREFORE, THE INSPECTION OF THE ACTUAL DEVICE WAS LIMITED. VISUAL INSPECTION REVEALED THE ACTUAL DEVICE WAS IN THE STATE OF BEING COMBINED WITH A GUIDE WIRE. THE CATHETER SHAFT HAD BEEN FRACTURED AT APPROXIMATELY 460 MM FROM THE DISTAL END. THE LENGTH OF EACH FRACTURED SEGMENT WAS MEASURED, AND THE TOTAL LENGTH WAS CONFIRMED TO BE COMPARABLE TO THAT OF A FACTORY-RETAINED SAMPLE OF THE INVOLVED PRODUCT CODE. RETRIEVED DISTAL SEGMENT: APPROXIMATELY 460 MM; PROXIMAL SEGMENT: APPROXIMATELY 840 MM, APPROXIMATELY 460 MM + APPROXIMATELY 840 MM APPROXIMATELY 1300 MM IN TOTAL. TOTAL LENGTH OF THE FACTORY-RETAINED SAMPLE OF THE INVOLVED PRODUCT CODE: APPROXIMATELY 1300 MM. MAGNIFYING INSPECTION FOUND THAT THE FRACTURE END OF BOTH SEGMENTS HAD BEEN DEFORMED IN A TAPERED SHAPE AND THEIR SHAPES OF DAMAGE WERE FIT TO EACH OTHER. THERE WAS A DENT ON THE FRACTURED DISTAL SEGMENT NEAR THE FRACTURE END, WHICH APPEARED TO HAVE BEEN CAUSED WHEN THE FRACTURED SEGMENT WAS RETRIEVED FROM THE PATIENT WITH A SNARE CATHETER. THE REINFORCEMENT HAD BEEN RAVELED STARTING FROM THE FRACTURE END AND EXPOSED. IT IS MOST UNLIKELY THAT THE ACTUAL DEVICE HAD A MISSING PORTION. VISUAL INSPECTION OF THE FACTORY-RETAINED SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT COMBINATION DID NOT FIND ANY FRACTURE OVER THE TOTAL LENGTH. MAGNIFYING INSPECTION OF THE FACTORY-RETAINED SAMPLE AFTER REMOVED FROM THE ATTACHED GUIDE WIRE DID NOT FIND ANY DEFORMATION, INCLUDING AN ELONGATION OR A CRUSH, ALONG THE TOTAL LENGTH. THE OUTER DIAMETER OF THE FACTORY-RETAINED SAMPLE WAS MEASURED ON APPROX. 460 MM FROM THE DISTAL END AND CONFIRMED TO MEET THE SPECIFICATIONS. OUTER DIAMETER AT APPROXIMATELY 460 MM FROM THE DISTAL END: 0.95 MM. MAGNIFYING INSPECTION OF THE LUMEN AT THE DISTAL END AND THE HUB DID NOT FOUND ANY ANOMALY INCLUDING AN OBSTRUCTION. REPRODUCTIVE TESTING WAS PERFORMED. A CURRENT PROGREAT SAMPLE IN THE STATE OF BEING COMBINED WITH AN ATTACHED GUIDE WIRE WAS PULLED IN BOTH DIRECTION FROM THE POINT APPROXIMATELY 460 MM FROM THE DISTAL END. (SAME LOCATION AS THE FRACTURE ON THE ACTUAL DEVICE). AS A RESULT, THE CATHETER BECAME FRACTURED AND THE REINFORCEMENT BECAME EXPOSED FROM THE FRACTURE END. MAGNIFYING INSPECTION OF THE FRACTURE FOUND THAT FRACTURE SEGMENT ON BOTH SIDES BECAME ELONGATED. THE DAMAGE SIMILAR TO THAT OBSERVED ON THE ACTUAL DEVICE WAS NOT DUPLICATED. A CURRENT PROGREAT SAMPLE WAS INSERTED IN A FACTORY-RETAINED ANGIOGRAPHIC CATHETER WHICH HAD A TWO-WAY STOPCOCK AT THE PROXIMAL END. THE STOPCOCK WAS TURNED. THE CATHETER BECAME CURVED AND FRACTURED AT TWO POINTS. THE DAMAGE SIMILAR TO THAT OBSERVED ON THE ACTUAL DEVICE WAS NOT DUPLICATED. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATIONS WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT, DO NOT REMOVE THE MICRO CATHETER SYSTEM BY FORCE. WITHDRAW THE CATHETER CAREFULLY TOGETHER WITH THE GUIDING CATHETER. REMOVING THE CATHETER BY FORCE MAY RESULT IN THE CATHETER BREAKAGE/SEPARATION, WHICH MAY NECESSITATE RETRIEVAL. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL DEVICE BECAME DAMAGED DUE TO SOME FACTORS (E.G. DUE TO HAVING BEEN EXPOSED TO CALCIFIED LESION), AND SUBSEQUENTLY EXPOSED TO A PULLING FORCE ON THAT DAMAGED POINT, RESULTING IN THE GENERATION OF THE FRACTURE. SINCE THE ACTUAL SAMPLE WAS INFECTIOUS, THE INSPECTION OF IT WAS LIMITED AS ABOVE. THE DEFINITE CAUSE OF THIS COMPLAINT WAS UNABLE TO BE CLARIFIED. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED PROGREAT WAS USED DURING A TACE CASE. CHEMOEMBOLIZATION FOLLOWED BY AN ANGIOGRAM WAS COMPLETED. WHILE BEING REMOVED FROM THE PATIENT, THE MICRO CATHETER BECAME FRACTURED. THE DISTAL 20 CM WAS FOUND REMAINED IN A VESSEL UNDER A FLUOROSCOPY; IT WAS RETRIEVED WITH A SNARE SUCCESSFULLY. THE VESSEL WAS CALCIFIED. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940155 PROGREAT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA NA 181225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention