PROGREAT
Report
- Report Number
- 9681834-2026-00059
- Event Type
- Malfunction
- Date Received
- April 10, 2026
- Date of Event
- February 23, 2026
- Report Date
- April 10, 2026
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQO
- PMA / PMN Number
- K033583
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
. D2A: CATHETER, CONTINUOUS FLUSH D2B: KRA D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. . G4: 510K: K033913. THE RETURNED DEVICES WERE PROGREAT CATHETERS (ACTUAL CATHETER) AND INTEGRATED GUIDE WIRE (ACTUAL GUIDE WIRE). COMBINATION TEST: THE ACTUAL GUIDE WIRE WAS INSERTED FROM THE HUB SIDE OF THE ACTUAL CATHETER. IT WAS CAUGHT INSIDE THE ANTI-KINK PROTECTOR AND COULD NOT BE INSERTED. APPEARANCE CONFIRMATION: ACTUAL CATHETER - NO ANOMALIES SUCH AS KINK OR CRUSH WERE FOUND OVER THE ENTIRE LENGTH. THE REINFORCING COIL HAD BEEN JUMBLED INSIDE THE ANTI-KINK PROTECTOR. FOREIGN MATTER WAS FOUND WITHIN THE LUMEN OF THE JUMBLED PART OF THE REINFORCING COIL. NO ANOMALY SUCH AS OBSTRUCTION WAS FOUND IN OTHER LUMENS. THE ANTI-KINK PROTECTOR WAS DISASSEMBLED IT HAD BEEN BUCKLED IN THE VICINITY OF THE ADHESIVE PART BETWEEN THE HUB AND THE CATHETER. BLACK SUBSTANCE WAS OBSERVED AT THE BUCKLED PART. ACTUAL GUIDEWIRE - IT HAD BEEN KINKED AT APPROXIMATELY 30MM FROM THE DISTAL END. IT HAD BEEN ABRADED OVER APPROXIMATELY 355MM TO APPROXIMATELY 1430MM FROM THE DISTAL END. THE OUTER COAT HAD PEELED OFF OVER APPROXIMATELY 770MM TO APPROXIMATELY 920MM FROM THE DISTAL END. THE BLACK SUBSTANCE IN THE BUCKLED PART OF THE ACTUAL CATHETER WAS THOUGHT TO BE THE PEELED PIECE OF THE OUTER LAYER COAT. IT HAD BEEN ABRADED TOWARD THE DISTAL END AT THE PEELED PART OF THE OUTER COAT. NO ANOMALY SUCH AS ABRASION WAS FOUND IN OTHER PARTS. 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. FUNCTION CONFIRMATION: THE OUTER DIAMETER OF THE ACTUAL CATHETER: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. THE INNER DIAMETER OF THE ACTUAL CATHETER: IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. THE OUTER DIAMETER OF THE ACTUAL GUIDEWIRE (NORMAL PART): IT MET THE FACTORY'S SPECIFICATION. NO ANOMALY WAS FOUND. LUBRICITY CONFIRMATION (HAND SENSORY): THE LUBRICITY WAS CONFIRMED AFTER PUTTING THE ACTUAL GUIDE WIRE IN WATER. IT WAS CAUGHT AT APPROXIMATELY 355 MM TO APPROXIMATELY 1125MM FROM THE DISTAL END. THE CAUGHT PART MATCHED THE ABRADED PART. NO ANOMALY WAS FOUND IN MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. SIMULATION TEST: SIMULATION TEST REGARDING THIS EVENT WAS PERFORMED IN THE PAST. 1. A GUIDEWIRE WAS PULLED OUT VIGOROUSLY FROM A FACTORY-RETAINED PROGREAT WITH INSUFFICIENT PRIMING, RESULTING IN RESISTANCE. 2. AFTER THE GUIDEWIRE WAS CONTINUOUSLY REMOVED UNDER RESISTANCE, IT BECAME BUCKLED IN THE VICINITY OF THE ADHESIVE PART BETWEEN THE CATHETER AND THE HUB INSIDE ANTI-KINK PROTECTOR. 3. IT WAS FOUND THAT SINCE THE SURFACE OF GUIDEWIRE WAS ABRADED AT THE BUCKLED PART OF CATHETER, THE OUTER LAYER COAT ON THE SURFACE OF GUIDEWIRE WAS PEELED OFF, AND THE PEELED OUTER LAYER COAT WAS FLARED TOWARD THE DISTAL SIDE. BASED ON THE INVESTIGATION RESULTS AND SIMULATION TEST RESULTS, AS A POSSIBLE CAUSE OF THIS CASE, THE FOLLOWING MECHANISM WAS INFERRED. 1. WHEN THE ACTUAL GUIDEWIRE WAS REMOVED, INSUFFICIENT PRIMING RESULTED IN HIGH FRICTION RESISTANCE BETWEEN THE INNER SURFACE OF THE ACTUAL CATHETER AND THE OUTER SURFACE OF THE ACTUAL GUIDEWIRE. WHEN THE ACTUAL GUIDEWIRE WAS REMOVED IN THIS STATE, THE CATHETER BUCKLED IN THE VICINITY OF THE ADHESIVE JOINT BETWEEN THE HUB INSIDE THE ANTI-KINK PROTECTOR AND THE CATHETER. 2. THE HYDROPHILIC COATING PEELED OFF AS THE SURFACE OF THE ACTUAL GUIDEWIRE WAS ABRADED AT THE BUCKLED PART OF THE ACTUAL CATHETER. IN ADDITION, THE PEELED OUTER COAT ADHERED TO THE LUMEN OF THE BUCKLED PART OF THE ACTUAL CATHETER. 3. AFTER THE ACTUAL GUIDEWIRE WAS REINSERTED INTO THE ACTUAL CATHETER, IT GOT CAUGHT AT THE BUCKLED PART OF THE CATHETER AND COULD NOT BE INSERTED. IN ADDITION, THE KINK ON THE ACTUAL GUIDE WIRE WAS THOUGHT TO HAVE BEEN CAUSED BY EXCESSIVE BENDING LOAD APPLIED TO THE INVOLVED PART WHEN THE ACTUAL GUIDE WIRE WAS INSERTED UNDER THE RESISTANCE. RELEVANT INSTRUCTIONS FOR USE (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. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.
TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CATHETER WAS DIFFICULT TO FLUSH, THE WIRE DID NOT PASS THROUGH. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145206 | PROGREAT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | TERUMO CORPORATION, ASHITAKA | MC-PP24131ZB | 250808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |