BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 19949555 · Received August 9, 2024

    Report

    Report Number
    9681834-2024-00138
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 23, 2024
    Report Date
    August 9, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: CONTACT: REQUESTED, NOT PROVIDED. E1: TELEPHONE NUMBER: REQUESTED, NOT PROVIDED. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: PMA/510(K): K033913. HISTORY INVESTIGATION: · THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE: NO ANOMALY WAS FOUND · PAST COMPLAINT FILE OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT#: NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND PROVIDED PHOTO: · THE ACTUAL CATHETER HAD BEEN CUT OFF. APPEARANCE CONFIRMATION: VISUAL INSPECTION OF THE ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS. · THE ACTUAL CATHETER AND THE GUIDEWIRE INTEGRATION TYPE HAD BEEN GOT STUCK. · IT HAD BEEN CUT OFF IN TWO SECTIONS AT APPROXIMATELY 1110MM - 1180MM FROM THE DISTAL END OF ACTUAL SAMPLE. · THE ACTUAL SAMPLE HAD BEEN ELONGATED TO APPROXIMATELY 1560MM, COMPARED TO THE EFFECTIVE LENGTH OF 1300MM. MAGNIFYING INSPECTION OF THE CUT SECTIONS OF ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS. · THE OUTER LAYER AND INNER LAYER HAD BEEN CUT OFF. · THE REINFORCEMENT COIL HAD BEEN EXPOSED AND DEFORMED. · THE EXPOSED SECTION AT THE INNER LAYER HAD BEEN BUCKLED. MAGNIFYING INSPECTION OF THE SECTIONS OTHER THAN THE CUT SECTIONS OF ACTUAL SAMPLE OBTAINED FOLLOWING RESULTS. · THE CATHETER HAD BEEN ELONGATED AT THE HAND SIDE BEYOND THE CUT SECTIONS OF ACTUAL SAMPLE. · NO ANOMALY SUCH AS DEFORMATION WAS FOUND AT THE DISTAL SIDE BEYOND THE CUT SECTIONS OF ACTUAL SAMPLE. THE SURFACE OF ACTUAL SAMPLE HAD BEEN ROUGHENED IN THE VICINITY OF CUT SECTIONS (ELECTRON MICROSCOPIC INSPECTION). - IT WAS INFERRED THAT SOME EXTERNAL FORCE WAS APPLIED TO THE INVOLVED SECTION. NO ANOMALY WAS FOUND IN THE CONDITION OF THE SURFACE OF GUIDEWIRE (MAGNIFYING INSPECTION). FUNCTION CONFIRMATION: · OUTER DIAMETER OF THE CATHETER (NORMAL SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. · INNER DIAMETER OF THE CATHETER (NORMAL SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. SIMULATION TEST: FOLLOWING SIMULATION TEST WAS PERFORMED. ASSUMING THAT PRIMING WAS INSUFFICIENT WHEN THE ACTUAL SAMPLE WAS REMOVED FROM THE HOLDER TUBE, A FACTORY-RETAINED PROGREAT WAS INTENTIONALLY STUCK INSIDE THE HOLDER TUBE AND ATTEMPTED TO REMOVE THE CATHETER IN THAT CONDITION. AS A RESULT, FOLLOWING EVENTS OCCURRED. · THE OUTER LAYER AND INNER LAYER WERE CUT OFF. · THE REINFORCEMENT COIL WAS EXPOSED AND DEFORMED. THESE CONDITIONS WERE LIKELY TO BE SIMILAR TO THOSE OF THE ACTUAL SAMPLE. CAUSE OF OCCURRENCE/CONCLUSION: AFTER THE ASSEMBLING PROCESS OF THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED, AND THE CUTTING FOUND IN THE ACTUAL SAMPLE COULD BE DETECTED IN THE VISUAL INSPECTION. THEREFORE, AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING MECHANISM WAS INFERRED. I. THE PRIMING INSIDE THE HOLDER TUBE WAS INSUFFICIENT, CAUSING STICKING BETWEEN THE ACTUAL SAMPLE AND THE HOLDER TUBE. II. WHEN AN ATTEMPT WAS MADE TO REMOVE THE ACTUAL SAMPLE IN THE STATE OF "1", PULLING FORCE WAS APPLIED TO THE INVOLVED SECTION, CAUSING IT TO CUT. RELEVANT IFU REFERENCE: "IF RESISTANCE IS FELT, DO NOT TRY TO REMOVE IT AGAINST THE RESISTANCE, BUT INJECT HEPARINIZED SALINE SOLUTION INTO ITS HOLDER AGAIN, AND TRY ONCE MORE." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN THEY OPENED THE MICROCATHETER FOR PRE-FLUSHING BEFORE TREATMENT, TOOK OUT AND FOUND THAT THE COATING OF THE MICROCATHETER BODY WAS BROKEN, AND THE MICROGUIDE WIRE COULD NOT BE PULLED OUT SMOOTHLY, AND REPLACED THE MICROCATHETER AND THEN CARRIED OUT SURGICAL TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462088 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA N/A 230616

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male