MAUDE Adverse Event Report: Terumo Corporation, Ashitaka PROGREAT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC*PE24131YB
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: it was reported that during a visceral procedure, the progreat broke off inside the patient.Additional information was received on 10 july 2026: there was no blood loss.The event occurred during the visceral procedure.The progreat fragment remains inside the patient.

• Brand Name: PROGREAT
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 50059904
• Report Number: 50059904
• Device Sequence Number: 10731108
• Product Code: DQO
• UDI-Device Identifier: 04987350729286
• UDI-Public: (01)04987350729286(17)271231(10)260123
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 07/28/2026
• Report Date (Section F): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC*PE24131YB
• Device Catalogue Number: MC*PE24131YB
• Device Lot Number: 260123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/06/2026
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/28/2026