MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC*PB2413Y
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: a microcatheter was positioned to the location of embolization.There was one tortuous portion where several coils were not able to advance despite the physicians attempts to flush catheter and reposition.Once it was decided to remove the microcatheter for an alternative, the catheter appeared damaged.Additional information was received on 07dec2025: ashitaka confirmed the tip of the actual sample was severed.Additional information was received on 08dec2025: there was no patient harm and no broken fragments inside the body.Additional information was received on 09dec2025: the progreat was delivered to the location where the physicians want to coil.A coil was delivered successfully, and the next coil did not.It was impossible to determine why, and the physician tried another, however it also would deliver past the tip of the progreat.When the progreat was removed, the physician indicated the tip was damaged.

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 23905667
• Report Number: 2243441-2025-00070
• Device Sequence Number: 15692116
• Product Code: DQO
• UDI-Device Identifier: 04987350781215
• UDI-Public: (01)04987350781215(17)270831(10)250910
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025
• Report Date (Section F): 12/29/2025

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*PB2413Y
• Device Catalogue Number: MC*PB2413Y
• Device Lot Number: 250910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2025
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/29/2025