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 medical corporation received the following information: it was reported that during a visceral procedure, the progreat broke off inside the patient.On 10 july 2026: additional information received: there was no blood loss.The event occurred during the visceral procedure.The progreat fragment remains inside the patient.
Additional Manufacturer Narrative
A1: patient identifier: not provided due to hospital policy.A2: age & date of birth: not provided due to hospital policy.A3b: sex: not provided due to hospital policy.A4: weight: not provided due to hospital policy.A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: unknown.The actual device was not available; therefore, the actual device will not be returned for evaluation.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Since the details of the circumstances under which this event occurred were unknown, and the actual device was not returned and investigation of it could not be performed, it was not possible to clarify the cause of occurrence.For the related report please see section h10 terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: PROGREAT
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• Manufacturer (Section G): Terumo Corporation, Ashitaka; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; +1(949)989-0491
• MDR Report Key: 50059905
• Report Number: 9681834-2026-00171
• Device Sequence Number: 18824136
• 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
• PMA/510(K) Number: K170223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown