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

Model Number	MC*PE24151YV
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following reported information: during the splenic arerty embolization, the progreat was inserted through glidecath (inside destination sheath) and advanced to the splenic artery.Per the medical doctor (md), the coil 5x16 cx became stuck and could not push or pull coil; therefore, a coil was deployed and attempted to push with 018 command wire.The wire could not push the coil, per md the "progreat broke".The md was able to recover the progreat and was able to release coil pack.Coil pack landed in the intended location, and progreat was removed and replaced.Embolization was then completed, successful, and the patient was ok.Later, the md stated he believed the progreat became stuck in glidecath due to inadequate flushing, and the coil became stuck for similar reasons.Additional information was received on 31dec2025: the patient was stable following the procedure.They were taken back to the operating room (or) for another procedure the following day, though it was not thought the previous procedure was at fault.The treatment was successful; the splenic artery was embolized resulting in reduction of bleeding from the spleen.No additional intervention was necessary to treat the splenic bleed.There were multiple coils deployed before the progreat "got stuck" and fractured.According to a member of the operative team, the physician had the progreat deep into the coil nest, inserted a 5x16 cx 18, tried to deploy; however, may have deployed the coil partially inside the catheter.When he pulled back on the progreat, it became kinked and would not release the coil.Then other wires were introduced to push the coil out.The physician then pulled the progreat back to the base catheter with the coil nest still attached.The last coil looked to have unraveled and was still in the progreat.The coil nest then was pushed back to the intended location either by catheter or blood flow (story was vague).They introduced a new progreat and were able to continue coiling the artery.Despite the challenges, the procedure was successful.Additional information was received on 07jan2026: the base catheter was a penumbra benchmark catheter, not a glidecath.Additional information was received on 05feb2026: they were not aware the tip fractured and were unsure if it was retained in the body (in the coil mass) or removed with the catheter and not included in the sample.

• Brand Name: PROGREAT
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 24305896
• Report Number: 2243441-2026-00006
• Device Sequence Number: 17452963
• Product Code: DQO
• UDI-Device Identifier: 04987350735287
• UDI-Public: (01)04987350735287(17)260228(10)240307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026
• Report Date (Section F): 02/10/2026

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 Expiration Date: 02/28/2026
• Device Model Number: MC*PE24151YV
• Device Catalogue Number: MC*PE24151YV
• Device Lot Number: 240307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2026
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5X16 CX18; DESTINATION SHEATH; PENUMBRA BENCHMARK CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/10/2026