BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 24939637 · Received April 21, 2026

    Report

    Report Number
    9681834-2026-00069
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 21, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: CATHETER, CONTINUOUS FLUSH. D2B: KRA. 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. E1: INITIAL REPORTER NAME: UNKNOWN. E1: PHONE NUMBER: UNKNOWN. G4: 510K: K033913. THE RETURNED DEVICES WERE THE PROGREAT CATHETER (ACTUAL CATHETER) AND COMPETITOR'S COIL WIRES (CONCOMITANT COIL WIRES); AN INTEGRATED GUIDEWIRE WAS NOT RETURNED. APPEARANCE CONFIRMATION: [ACTUAL CATHETER]: THE HUB HAD BEEN OBSTRUCTED WITH THE FRACTURED PIECE OF THE CONCOMITANT COIL WIRE. NO ANOMALY SUCH AS OBSTRUCTION WAS FOUND IN OTHER PARTS. THE FRACTURED PIECE OF THE CONCOMITANT GUIDEWIRE HAD BEEN JUMBLED INSIDE THE ANTI-KINK PROTECTOR. THE FRACTURED PIECE OF THE CONCOMITANT GUIDEWIRE HAD BEEN UNDULATED INSIDE THE ANTI-KINK PROTECTOR. NO ANOMALY SUCH AS OBSTRUCTION WAS FOUND IN OTHER LUMENS. [CONCOMITANT COIL WIRE]: IT HAD BEEN SIGNIFICANTLY JUMBLED IN THE COIL PART. FUNCTION CONFIRMATION: THE OUTER DIAMETER OF THE ACTUAL CATHETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. THE INNER DIAMETER OF THE ACTUAL CATHETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. NO ANOMALY WAS FOUND IN MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. AS A POSSIBLE CAUSE OF THIS CASE, THE FOLLOWING MECHANISM WAS INFERRED. 1) DURING THE INSERTION OF THE COIL WIRE INTO THE CATHETER, THE COIL BECAME JUMBLED DUE TO SOME FACTOR AND GOT STUCK. 2) WHEN ATTEMPTING TO REMOVE THE COIL WIRE IN THE STATE OF 1, THE COIL WIRE WAS SEVERED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: " CAUTIONS IF ANY RESISTANCE IS FELT WHILE REMOVING THE GUIDE WIRE, DO NOT REMOVE THE GUIDE WIRE BY FORCE. THE RESISTANCE MAY INDICATE INSUFFICIENT LUBRICITY OF THE GUIDE WIRE. FLUSH THE CATHETER AGAIN WITH HEPARINIZED SALINE SOLUTION. IF ANY RESISTANCE IS FELT WHILE REMOVING THE GUIDE WIRE, DO NOT REMOVE THE GUIDE WIRE BY FORCE. DRAWING BACK THE GUIDE WIRE AGAINST RESISTANCE MAY CAUSE THE CATHETER KINK. CAREFULLY REMOVE THE GUIDE WIRE TOGETHER WITH THE CATHETER." TERUMO MEDICAL CORPORATION (TMC) (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

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PROGREAT WAS INTRODUCED WITHOUT ANY ISSUE AND THE COILS WERE RELEASED. WHEN THE DEVICE WAS RETRIEVED, IT COULD BE OBSERVED THAT THE COATING WAS DETACHED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261602 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PE28131 240625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown