BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT CATHETER

    MDR report key: 20452803 · Received October 15, 2024

    Report

    Report Number
    9681834-2024-00175
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    August 12, 2024
    Report Date
    October 15, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: DISTRIBUTOR. G4: PMA/510(K): K033913. APPEARANCE CONFIRMATION: THE ACTUAL SAMPLE UPON RECEIPT WAS A PROGREAT CATHETER (ACTUAL SAMPLE) AND AN INTEGRATED GUIDEWIRE COMBINED (VISUAL INSPECTION). IT WAS POSSIBLE TO REMOVE THE GUIDEWIRE. THE OUTER LAYER AND INNER LAYER OF THE ACTUAL SAMPLE HAD BEEN CUT (MAGNIFYING INSPECTION). THE OUTER LAYER AND INNER LAYER HAD BEEN PARTIALLY CONNECTED AT THE CUT SECTION AND HAD BEEN ELONGATED (MAGNIFYING INSPECTION). THE REINFORCEMENT COIL HAD BEEN EXPOSED IN THE VICINITY OF CUT SECTION (MAGNIFYING INSPECTION). THE OUTER LAYER IN THE VICINITY OF CUT SECTION HAD BEEN ABRADED AND ROUGHENED (ELECTRON MICROSCOPIC INSPECTION). IT WAS INFERRED THAT SOME HARD OBJECT CAME INTO STRONG CONTACT WITH THE INVOLVED SECTION. 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. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER FOUND NO ANOMALY. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. SIMULATION TEST: IN ORDER TO CONFIRM THE MECHANISM BY WHICH THE ACTUAL SAMPLE CUT, THE FOLLOWING SIMULATION TEST WAS PERFORMED. A FACTORY-RETAINED PROGREAT WAS INTENTIONALLY SCRATCHED WITH THE CUTTING TOOL, THEN THE DISTAL END OF CATHETER WAS TRAPPED. SUBSEQUENTLY, PULLING FORCE WAS APPLIED TO THE CATHETER IN THAT CONDITION. AS A RESULT, THE CATHETER WAS CUT AT THE SCRATCHED SECTION. THE APPEARANCE OF AREA IN THE VICINITY OF CUT SECTION WAS CONFIRMED. THE FOLLOWING FACTORS WERE FOUND (MAGNIFYING INSPECTION). THE OUTER LAYER AND INNER LAYER WERE CUT. THE OUTER LAYER AND INNER LAYER WERE PARTIALLY CONNECTED AND WERE ELONGATED. THESE CONDITIONS WERE LIKELY TO BE SIMILAR TO THOSE OF THE ACTUAL SAMPLE. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING MECHANISM WAS INFERRED. AFTER REMOVING THE ACTUAL SAMPLE FROM THE PACKAGE, SOME HARD OBJECT CAME INTO CONTACT WITH THE INVOLVED SECTION, CAUSING A SCRATCH. THE DISTAL END OF ACTUAL SAMPLE WAS TRAPPED FOR SOME REASON. PULLING FORCE WAS APPLIED TO THE ACTUAL SAMPLE, CAUSING THE INVOLVED SECTION TO CUT. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) 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 THE TIP OF THE CATHETER WAS BROKEN DURING SALINE FLUSHING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296116 PROGREAT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PP27151 231102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown