BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 22629159 · Received July 28, 2025

    Report

    Report Number
    9681834-2025-00138
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 28, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . E1: INITIAL REPORTER NAME: UNKNOWN E1: ESTABLISHMENT NAME: (B)(6). E1: PHONE NUMBER: UNKNOWN G4: 510(K) NUMBER: K033913. THE ACTUAL DEVICE UPON RECEIPT WAS A PROGREAT CATHETER (ACTUAL CATHETER) AND AN INTEGRATED GUIDEWIRE (ACTUAL GUIDEWIRE). APPEARANCE CONFIRMATION [ACTUAL CATHETER] - NO ANOMALY SUCH AS A KINK OR CRUSH WAS FOUND OVER THE ENTIRE LENGTH (VISUAL INSPECTION/ MAGNIFYING INSPECTION). - A FOREIGN SUBSTANCE WAS FOUND IN THE LUMEN OF HUB (X-RAY FLUOROSCOPIC INSPECTION/ X-RAY FLUOROSCOPIC (CT) INSPECTION). - NO ANOMALY SUCH AS AN OBSTRUCTION IN THE LUMEN WAS FOUND IN OTHER SECTIONS (X-RAY FLUOROSCOPIC INSPECTION). - THE HUB WAS CUT LONGITUDINALLY AND THE LUMEN WAS CONFIRMED. - A TRANSPARENT SUBSTANCE WAS FOUND IN THE LUMEN OF HUB (MAGNIFYING INSPECTION). - AN ABRASION WAS FOUND IN THE LUMEN OF HUB, TOWARD THE HAND SIDE DIRECTION (MAGNIFYING INSPECTION). - IT WAS LIKELY THAT THE ABRASION OCCURRED BY STRONG CONTACT WITH A TRANSPARENT SUBSTANCE. · THE TRANSPARENT SUBSTANCE FOUND WAS COLLECTED, AND COMPONENT ANALYSIS WAS PERFORMED. - IT WAS A SPECTRUM THAT WOULD BE DETECTED IN MATERIALS CONTAINING SILICON, SO THE TRANSPARENT SUBSTANCE WAS LIKELY TO BE A SILICATE (FT-IR). - FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY METHOD): AN ANALYSIS METHOD ANALYZING THE SPECTRUM OBTAINED BY IRRADIATING THE MEASUREMENT TARGET WITH INFRARED RAYS. [ACTUAL GUIDEWIRE] - THE OUTER COAT HAD BEEN PEELED OFF FROM THE DISTAL END TO APPROXIMATELY 355MM FROM THE DISTAL END (VISUAL INSPECTION). - THERE WERE INTERMITTENT ABRASIONS AND PEELING OF THE OUTER COAT FROM THE DISTAL END TO APPROXIMATELY 1000MM FROM THE DISTAL END (MAGNIFYING INSPECTION). - NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS (MAGNIFYING INSPECTION). - ABRASIONS WERE FOUND TOWARD THE DISTAL DIRECTION AT THE SECTIONS WHERE THE OUTER COAT HAD PEELED OFF (ELECTRON MICROSCOPIC INSPECTION). - ABRASIONS WERE FOUND TOWARD THE DISTAL DIRECTION AT APPROX. 1000MM FROM THE DISTAL END (MAGNIFYING INSPECTION). - IT WAS LIKELY THAT WHEN ACTUAL GUIDEWIRE WAS REMOVED, SOME HARD OBJECT CAME INTO CONTACT WITH THE INVOLVED SECTION. - THE OUTER COAT OF ACTUAL DEVICE WAS INTENTIONALLY PEELED OFF TO CONFIRM THAT IT WAS IN CLOSE CONTACT. NO ANOMALY SUCH AS FLOATING OR GAP ON THE COAT WAS FOUND (MAGNIFYING INSPECTION). FUNCTION CONFIRMATION - OUTER DIAMETER OF ACTUAL CATHETER: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. - INNER DIAMETER OF ACTUAL CATHETER: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. - OUTER DIAMETER OF ACTUAL GUIDEWIRE (NORMAL SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. HISTORY INVESTIGATION - THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER: 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. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF OCCURRENCE, THE FOLLOWING MECHANISMS WERE INFERRED. 1. AFTER THE CATHETER WAS PRIMED, THE TRANSPARENT SUBSTANCE WAS MIXED INTO THE CATHETER LUMEN. 2. WHEN THE GUIDEWIRE WAS REMOVED IN THE STATE OF "1", THE TRANSPARENT SUBSTANCE MOVED ALONG WITH THE GUIDEWIRE TOWARD THE CATHETER'S HAND SIDE AND WAS OBSTRUCTED IN THE LUMEN OF HUB. 3. WHEN THE GUIDEWIRE WAS FURTHER REMOVED IN THE STATE OF "2", IT WAS ABRADED AGAINST THE TRANSPARENT SUBSTANCE, CAUSING ABRASIONS AND PEELING OF THE OUTER COAT. 4. WHEN ATTEMPTING TO INSERT THE GUIDEWIRE INTO THE CATHETER, THE TRANSPARENT SUBSTANCE WAS OBSTRUCTED IN THE CATHETER LUMEN, AND THE OUTER COAT WAS PEELED OFF ON THE GUIDEWIRE. DUE TO THESE EVENT, THE GUIDEWIRE COULD NOT BE INSERTED. REGARDING THE TRANSPARENT SUBSTANCE, SINCE THE DETAILS OF PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO IDENTIFY WHAT IT WAS. TERUMO MEDICAL CORPORATION (TMC) (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 PRODUCT WAS PRE-FLUSHED BEFORE SURGERY. DURING THE OPERATION, THE MICROCATHETER HAD DIFFICULTY PASSING THROUGH. AFTER REPLACING THE MICROCATHETER, THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609652 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PE27131 240520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown