BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 21845292 · Received April 15, 2025

    Report

    Report Number
    9681834-2025-00052
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 15, 2025
    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 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. G4: 510K: K033583, K033913. THE ACTUAL DEVICES RECEIVED WERE A PROGREAT CATHETER (ACTUAL DEVICE #1) AND A DEVICE CONSISTING OF A CATHETER COMBINED WITH AN INTEGRATED GUIDEWIRE (ACTUAL DEVICE #2). THE APPEARANCE CONFIRMATION OF ACTUAL DEVICE #1 REVEALED THAT THE OUTER AND INNER LAYERS HAD BEEN CUT, AND THE REINFORCEMENT COIL HAD BEEN EXPOSED AT APPROXIMATELY 5 MILLIMETERS FROM THE DISTAL END (VISUAL INSPECTION AND MAGNIFYING INSPECTION). AT THE CUT SECTION, THE OUTER AND INNER LAYERS HAD BEEN PARTIALLY CONNECTED AND ELONGATED (MAGNIFYING INSPECTION). THE OUTER LAYER IN THE VICINITY OF THE 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. THE FUNCTION CONFIRMATION OF THE OUTER DIAMETER OF THE CATHETER (NORMAL SECTION) SHOWED THAT IT MET THE FACTORY'S SPECIFICATIONS, WITH NO ANOMALIES FOUND. SIMULATION TESTING WAS CONDUCTED TO CONFIRM THE MECHANISM BY WHICH THE ACTUAL DEVICE WAS CUT. THE DISTAL END OF A FACTORY-RETAINED PROGREAT WAS INSERTED INTO THE STOPCOCK OF A FACTORY-RETAINED RADIFOCUS GLIDECATH (ANGIOGRAPHIC CATHETER), AND THE STOPCOCK OF THE ANGIOGRAPHIC CATHETER WAS CLOSED BY APPROXIMATELY 90 DEGREES. AFTER OPERATING THE STOPCOCK, THE PROGREAT WAS REMOVED FROM THE ANGIOGRAPHIC CATHETER AND VISUALLY INSPECTED. AS A RESULT, THE OUTER AND INNER LAYERS WERE CUT, AND THE REINFORCEMENT COIL WAS EXPOSED. AT THE CUT SECTION, THE OUTER AND INNER LAYERS HAD BEEN PARTIALLY CONNECTED AND ELONGATED. THIS CONDITION WAS LIKELY SIMILAR TO THAT OF THE ACTUAL DEVICE. FOR ACTUAL DEVICE #2, A COMBINATION TEST WAS CONDUCTED WHERE PRIMING WAS PERFORMED WITH THE CATHETER AND GUIDEWIRE COMBINED. IT WAS CONFIRMED THAT LIQUID CAME OUT OF THE DISTAL END WITHOUT RESISTANCE. AFTER PRIMING THE CATHETER, THE GUIDEWIRE WAS REMOVED WITHOUT RESISTANCE OVER ITS ENTIRE LENGTH. SIMILARLY, AFTER PRIMING THE CATHETER, THE GUIDEWIRE WAS INSERTED WITHOUT RESISTANCE OVER ITS ENTIRE LENGTH. THE APPEARANCE CONFIRMATION BY MAGNIFYING INSPECTION REVEALED NO ANOMALIES, SUCH AS KINKS OR CRUSHES, OVER THE ENTIRE LENGTH OF THE CATHETER. THE FUNCTION CONFIRMATION REVEALED THAT THE OUTER AND INNER DIAMETERS OF THE CATHETER MET THE FACTORY'S SPECIFICATIONS, WITH NO ANOMALIES FOUND. SIMILARLY, THE OUTER DIAMETER OF THE GUIDEWIRE MET THE FACTORY'S SPECIFICATIONS, AND NO ANOMALIES WERE FOUND. ADDITIONALLY, THE SLIDING RESISTANCE OF THE GUIDEWIRE SHOWED NO ANOMALIES WHEN COMPARED TO A FACTORY-RETAINED PRODUCT. THE HISTORICAL INVESTIGATION REVEALED THAT THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT # SHOWED NO ANOMALIES FOR EACH DEVICE. ADDITIONALLY, THE PAST COMPLAINT FILE FOR THE PRODUCT WITH THE PRODUCT CODE/LOT# INVOLVED INDICATED THAT NO OTHER SIMILAR REPORTS FROM OTHER FACILITIES WERE FOUND FOR EACH DEVICE. FOR ACTUAL DEVICE #1, BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE DEVICE WAS CUT DUE TO SOME EXTERNAL FORCE BEING APPLIED TO THE INVOLVED SECTION. HOWEVER, SINCE THE DETAILS OF THE PROCEDURE ARE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE EXACT CAUSE OF THE OCCURRENCE. FOR ACTUAL DEVICE #2, BASED ON THE INVESTIGATION RESULTS, NO ANOMALIES WERE FOUND IN THE MANUFACTURING RECORD, THE SHIPPING INSPECTION RECORD, OR THE COMBINATION TEST RESULTS OF THE DEVICE. RELEVANT IFU REFERENCE: IF THE GUIDING CATHETER IS FITTED WITH A STOPCOCK, DO NOT CLOSE THE STOPCOCK WITH THE MICRO CATHETER SYSTEM INSIDE THE GUIDING CATHETER. THE MICRO CATHETER SYSTEM MAY BE BROKEN. TERUMO MEDICAL CORPORATION (TMC) (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 THE PROCEDURE, THE DOCTOR FOUND IT DIFFICULT TO INSERT THE PROGREAT INTO THE CATHETER. UPON RETRIEVAL, SHE DISCOVERED THAT THE TIP OF THE MICROCATHETER WAS DEFORMED. THE DOCTOR ATTEMPTED TO CONTINUE THE PROCEDURE WITH ANOTHER PROGREAT, BUT FOUND THIS PIECE DRY, STICKY, AND DIFFICULT TO FLUSH. EVENTUALLY, THE DOCTOR COMPLETED THE PROCEDURE WITH A THIRD PROGREAT. THE FINAL IMPACT TO THE PATIENT WAS NO HARM. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION RECEIVED ON 19 MAR 2025: FOR Q1, THE USER USED AN OPTITORQUE CATHETER WITH PROGREAT, BUT DID NOT MENTION WHETHER A STOPCOCK WAS USED. ADDITIONAL INFORMATION RECEIVED ON 25 MAR 2025: THE USER REPLIED THAT A STOPCOCK SHOULD BE USED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439981 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PP24131ZB 241001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OPTITORQUE CATHETER