BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 23606627 · Received November 20, 2025

    Report

    Report Number
    9681834-2025-00211
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 20, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: BIOMEDICAL ENGINEER. G4: 510K: K033913. APPEARANCE CONFIRMATION [ACTUAL GUIDEWIRE]. THE INTERMITTENT PEELING OF THE OUTER LAYER COAT AND THE EXPOSURE OF THE WIRE STRAND WERE OBSERVED ALONG THE DISTAL END TO APPROXIMATELY 510 MM FROM THE DISTAL END. THE CONTINUOUS ABRASIONS WERE OBSERVED ON THE OUTER LAYER COAT ALONG THE DISTAL END TO APPROXIMATELY 1360 MM FROM THE DISTAL END. A FLARE OF THE OUTER LAYER COAT TOWARDS THE DISTAL END WAS OBSERVED AT APPROXIMATELY 175MM FROM THE DISTAL END. ROUGHNESS WAS OBSERVED ON THE OUTER LAYER COAT AT APPROXIMATELY 170 MM FROM THE DISTAL END. THE DISTAL END OF THE WIRE STRAND HAD BEEN TAPERED. DIMPLE PATTERNS WERE OBSERVED ON THE TOP SURFACE OF THE DISTAL END OF THE WIRE STRAND. THE DISTAL END OF THE WIRE STRAND WAS THOUGHT TO HAVE BEEN SEVERED. THE OUTER LAYER COAT OF THE ACTUAL DEVICE WAS INTENTIONALLY PEELED OFF TO CHECK THE ADHESION CONDITION, AND NO ANOMALIES SUCH AS LIFTING OR GAPS WERE OBSERVED. SIMULATION TEST: THE FOLLOWING SIMULATION TEST WAS PERFORMED IN THE PAST. WHEN A TENSILE LOAD WAS APPLIED TO THE GUIDEWIRE WITH IT STUCK, THE GUIDEWIRE WAS SEVERED. THE DISTAL END OF THE SEVERED WIRE STRAND WAS OBSERVED TO BE TAPERED. DIMPLE PATTERNS WERE OBSERVED ON THE TOP SURFACE. IT WAS THOUGHT TO BE SIMILAR TO THE CONDITION OF THE ACTUAL DEVICE. ACTUAL CATHETER - CRUSHES WERE OBSERVED AT APPROXIMATELY 80MM, 350MM, 765MM, AND 1120MM FROM THE DISTAL END. NO ANOMALY SUCH AS ABRASION WAS FOUND IN THE CRUSHED PART. THE DISTAL END OF THE GUIDEWIRE IS PLACED INSIDE THE CATHETER AT APPROXIMATELY 1240MM FROM THE DISTAL END. THE GUIDE WIRE WAS PLACED ALONG INSIDE THE ANTI-KINK PROTECTOR. NO ANOMALIES SUCH AS CRUSHES OR KINKS WERE FOUND IN OTHER PARTS. OBSTRUCTION OF FOREIGN SUBSTANCE AND JUMBLING OF THE REINFORCING COIL WERE OBSERVED INSIDE THE ANTI-KINK PROTECTOR. A GUIDE WIRE IS PLACED ALONG APPROXIMATELY 1240 MM FROM THE DISTAL END TO THE OBSTRUCTED PART. NO ANOMALY SUCH AS OBSTRUCTION IN OTHER LUMENS. APPEARANCE CONFIRMATION OF THE ANTI-KINK PROTECTOR AFTER DISASSEMBLED. A BUCKLING OF THE CATHETER WAS OBSERVED AT THE INVOLVED PART. A BLACK FOREIGN SUBSTANCE WAS OBSTRUCTED AT THE INVOLVED PART. THE BLACK FOREIGN SUBSTANCE WAS THOUGHT TO BE THE OUTER LAYER COAT OF THE GUIDEWIRE. SIMULATION TEST THE FOLLOWING SIMULATION TEST WAS PERFORMED IN THE PAST. WITH PROGREAT INSUFFICIENTLY PRIMED, THE GUIDEWIRE WAS FORCEFULLY REMOVED FROM THE CATHETER. BUCKLING OCCURRED IN THE VICINITY OF THE ADHESIVE JOINT BETWEEN THE HUB AND CATHETER INSIDE THE ANTI-KINK PROTECTOR. THE OUTER LAYER COAT PEELED OFF ON THE SURFACE OF THE GUIDEWIRE AFTER IT WAS REMOVED. THE OUTER LAYER COAT FLARED TOWARD THE DISTAL END AT THE PEELED PART. IT WAS SIMILAR TO THE CONDITION OF THE ACTUAL DEVICE. DIMENSIONS. THE OUTER DIAMETER OF THE CATHETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATION. NO ANOMALY WAS FOUND. THE INNER DIAMETER OF THE CATHETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATION. NO ANOMALY WAS FOUND. THE OUTER DIAMETER OF THE GUIDEWIRE: IT MET THE FACTORY'S SPECIFICATION. NO ANOMALY WAS FOUND. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER. NO ANOMALY WAS FOUND IN MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. CAUSE OF OCCURRENCE BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. AS ONE OF THE POSSIBILITIES, IT WAS INFERRED THAT THIS CASE OCCURRED WITH THE FOLLOWING MECHANISM. 1. WHEN THE GUIDEWIRE WAS REMOVED WITH IT INSUFFICIENTLY PRIMED, THE FRICTIONAL RESISTANCE BETWEEN THE INNER SURFACE OF THE CATHETER AND THE OUTER SURFACE OF THE GUIDEWIRE INCREASED, CAUSING RESISTANCE. 2. SINCE THE GUIDE WIRE WAS REMOVED CONTINUOUSLY UNDER RESISTANCE, THE CATHETER WAS BUCKLED INSIDE THE ANTI-KINK PROTECTOR, NARROWING THE LUMEN. 3. IT WAS REMOVED CONTINUOUSLY UNDER THE CONDITION OF (2), CAUSING THE GUIDE WIRE TO BECOME STUCK. 4. IT WAS REMOVED CONTINUOUSLY UNDER THE CONDITION OF (3), AND A TENSILE LOAD WAS APPLIED TO THE INVOLVED PART, RESULTING IN THE GUIDEWIRE BEING SEVERED. RELEVANT IFU REFERENCE: MAKE SURE THAT THE LOCK ADAPTER IS NOT LOOSE. INJECT HEPARINIZED SALINE SOLUTION INTO THE GUIDE WIRE HUB USING THE ATTACHED 2.5 ML LUER LOCK SYRINGE. IN ORDER TO PRIME THE CATHETER SUFFICIENTLY, SLOWLY INJECT AT LEAST 1 ML OF THE SOLUTION INTO THE CATHETER UNTIL MORE THAN 10 DROPS OF THE SOLUTION APPEAR OUT OF ITS TIP. TO MAINTAIN SURFACE LUBRICITY, IMMERSE THE CATHETER AND THE GUIDE WIRE ASSEMBLY IN A HEPARINIZED SALINE SOLUTION BATH OR PUT IT INTO ITS HOLDER FILLED WITH HEPARINIZED SALINE SOLUTION. PRIME THE CATHETER AND GUIDE WIRE SUFFICIENTLY. MANIPULATION OF AN INSUFFICIENTLY PRIMED CATHETER MAY CAUSE WRINKLING, SEPARATION OF THE CATHETER, AND/OR ABRASION OF THE HYDROPHILIC COATING ON THE GUIDE WIRE. 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: IT IS REPORTED THAT THE GUIDEWIRE HAD BROKEN INSIDE THE CATHETER AND THAT A PART OF THE URETHANE COATING ON THE WIRE HAD PEELED OFF. ADDITIONAL INFORMATION WAS RECEIVED ON 12NOV2025: THE GUIDEWIRE HAD BROKEN INSIDE THE CATHETER, BUT IT APPEARED ALL FRAGMENTS REMAINED WITHIN THE CATHETER. ADDITIONALLY, PART OF THE URETHANE COATING ON THE WIRE HAD PEELED OFF. THERE WAS NO BLOOD PRESENT ON THE ACTUAL SAMPLE, THE DEVICE BROKE OUTSIDE OF THE BODY. THERE WAS NO PATIENT INJURY, NO HARM AND NO RISK OF SERIOUS HARM WAS REPORTED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578489 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PP24131ZB 241211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown