PROGREAT
Report
- Report Number
- 9681834-2025-00135
- Event Type
- Injury
- Date Received
- July 30, 2025
- Date of Event
- July 4, 2025
- Report Date
- July 30, 2025
- Manufacturer
- TERUMO CORPORATION, ASHITAKA
- Product Code
- DQO
- PMA / PMN Number
- K033583
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. E3: OCCUPATION: PHARMACIST AND MATERIOVIGILANCE MANAGER. G4: 510(K) NUMBER: K033913. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. 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 NUMBER: NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5 AND H6, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE UPON RECEIPT WAS ONLY A PROGREAT (ACTUAL DEVICE) WITH THE DISTAL END CUT OFF, AND THE CUT PIECE AND INTEGRATED GUIDEWIRE WERE NOT RETURNED. TOTAL LENGTH OF THE ACTUAL DEVICE (DISTAL END - STRAIN RELIEF): APPROXIMATELY 1265MM. SINCE THE TOTAL LENGTH OF THIS PRODUCT IS 1300MM, THE CUT PIECE WAS LIKELY TO BE APPROXIMATELY 35MM. APPEARANCE CONFIRMATION: THE OUTER LAYER, INNER LAYER AND REINFORCEMENT COIL HAD BEEN CUT OFF AT THE CUT SECTION (MAGNIFYING INSPECTION). THE OUTER LAYER HAD BEEN TAPERED AT THE CUT SECTION (MAGNIFYING INSPECTION). NO ANOMALY SUCH A CUTTING, KINK OR CRUSH WAS FOUND IN OTHER SECTIONS (MAGNIFYING INSPECTION). ABRASIONS TOWARDS THE DISTAL DIRECTION WERE FOUND AT THE CUT SECTION (ELECTRON MICROSCOPIC INSPECTION). IT WAS LIKELY THAT SOME HARD OBJECT CAME INTO STRONG CONTACT WITH THE INVOLVED SECTION. THE OUTER LAYER AT THE CUT SECTION HAD BEEN TORN TOWARD THE DISTAL DIRECTION (ELECTRON MICROSCOPIC INSPECTION). IT WAS LIKELY THAT THE ACTUAL DEVICE WAS CUT OFF DUE TO THE PULLING FORCE APPLIED ON IT. FUNCTION CONFIRMATION: OUTER DIAMETER OF THE CATHETER (NORMAL SECTION IN THE VICINITY OF CUT SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND DIMENSIONS OF THE ACTUAL DEVICE. AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS LIKELY THAT DURING INSERTION OF PROGREAT INTO THE PATIENT'S BODY, THE DISTAL END OF PROGREAT WAS TRAPPED FOR SOME FACTOR. IN THIS STATE, PULLING FORCE WAS APPLIED, CAUSING IT TO ELONGATE, AND THE OUTER LAYER WAS CUT OFF. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT, DO NOT REMOVE THE MICRO CATHETER SYSTEM BY FORCE. WITHDRAW THE CATHETER CAREFULLY TOGETHER WITH THE GUIDING CATHETER. REMOVING THE CATHETER BY FORCE MAY RESULT IN THE CATHETER BREAKAGE/SEPARATION, WHICH MAY NECESSITATE RETRIEVAL."
THE USER FACILITY REPORTED THAT DURING BRONCHIAL EMBOLIZATION ON THE PATIENT, WHEN THE OPERATOR WAS MANIPULATING THE MICROCATHETER IN THE ARTERY, THE DISTAL END OF THE DEVICE WAS SEVERED (APPROXIMATELY 5 CM). RUPTURE OF A DISTAL FRAGMENT OF THE MICROCATHETER IN THE RIGHT SUBCLAVIAN ARTERY AT THE START OF THE PROCEDURE, WITH UNSUCCESSFUL LASSO RECOVERY ATTEMPTS AND MIGRATION OF THE FRAGMENT INTO THE HUMERAL ARTERY (ELBOW CREASE), WITH NO SIGN OF ACUTE ISCHEMIA OF THE RIGHT UPPER LIMB. THE ALLEN TEST SHOWED GOOD PATENCY OF THE PALMAR ARCH. THE INTRODUCTION OF PREVENTIVE ANTICOAGULATION WAS CONSIDERED IN CONJUNCTION WITH VASCULAR SURGEONS, DEPENDING ON THE BENEFIT-RISK BALANCE. REMOVAL OF THE MICROCATHETER FRAGMENT WILL BE DISCUSSED. CLINICAL CONSEQUENCES AND CURRENT STATUS OF PATIENT/PERSON INVOLVED: 5 CM FRAGMENT OF MICROCATHETER IN HUMERAL ARTERY. THERE WERE NO SIGNS OF ACUTE ISCHEMIA OF THE RIGHT UPPER LIMB. GOOD PALMAR ARCH PATENCY. ACTIONS TAKEN FOR THE PATIENT IN RELATION TO THE DEVICE: INTRODUCTION OF PREVENTIVE ANTICOAGULATION CONSIDERED WITH VASCULAR SURGEONS ACCORDING TO THE BENEFIT-RISK BALANCE. THE PROCEDURE OUTCOME WAS NOT REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: AN ATTEMPT AT ENDOVASCULAR EXTRACTION WAS MADE ON (B)(6), IN INTERVENTIONAL RADIOLOGY; HOWEVER, IT WAS UNSUCCESSFUL, WITH THE MICROCATHETER MIGRATING INTO THE RIGHT ULNAR ARTERY. AN OPINION WAS REQUESTED FROM VASCULAR SURGEONS, WHO DID NOT RECOMMEND SURGERY (PROBABLY MORE HARMFUL THAN BENEFICIAL). IT WAS AGREED TO CONTINUE LONG-TERM ANTIPLATELET THERAPY TO REDUCE THE RISK OF ARTERIAL THROMBOSIS; HOWEVER, IT WAS DECIDED TO POSTPONE CURATIVE ANTICOAGULATION GIVEN THE CIRCUMSTANCES. HOWEVER, THE PRESENCE OF THIS MICROCATHETER IN THE ULNAR ARTERY WAS AN ABSOLUTE AND DEFINITIVE CONTRAINDICATION TO PERFORMING ARTERIAL BLOOD GAS ANALYSIS IN THE RIGHT RADIAL ARTERY, DUE TO THE MAJOR RISK OF ACUTE ISCHEMIA. THERE WAS AN INDICATION TO PERFORM A DOPPLER ULTRASOUND OF THE RIGHT UPPER LIMB IN ONE MONTH TO CHECK THE PATENCY OF THE ULNAR ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514860 | PROGREAT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | TERUMO CORPORATION, ASHITAKA | MC-PP27131 | 241001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Other |