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
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: terumo executive territory manager.The returned device was only progreat (actual catheter), whose distal end had been severed, and severed piece was not returned.Total length: approximately 1125mm.(from the distal end to the anti-kink protector) since this is the product with the total length of 1300mm, the severed piece was estimated to be 175mm.Appearance confirmation - it had been severed at the distal end.It had been crushed in the vicinity of the severed part.It had been crushed at approx.680mm from the distal end.No anomaly such as crush was found in other parts.It had been abraded at the side of the severed part.It had been torn off in the outer and inner layer of the severed part.It was inferred that it became severed due to the tensile load applied while some hard object came into contact with the involved part.Dimension: the outer diameter of the catheter (normal part in the vicinity of the severed part): it met the factory's specifications.No anomaly was found.History investigation of the involved product code/lot number no anomaly was found in the manufacturing record and shipping inspection record.No similar event was found in the past complaint file.Based on the investigation result, no anomaly was found in the manufacturing records or dimensions of the actual device.As one of the possibilities regarding this case, when progreat was inserted into the body, the involved part was trapped due to some factor and the tensile load was applied under that condition, causing it to be severed.The ifu indicates the following: if any resistance is felt, do not remove the micro catheter system byforce.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.Ashitaka factory manufacturing process assures the quality of this product by performing the following work and inspections.The product is always flowed with a core wire inserted in the lumen to assure the catheter lumen.In the product assembling process, 100% visual inspection of the outer diameter is performed to ensure that there is no anomaly in the outer diameter of catheter.Before the product packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a sever or crush.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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; 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 ; 9499890491
• MDR Report Key: 23905669
• Report Number: 9681834-2025-00240
• Device Sequence Number: 8955255
• 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
• PMA/510(K) Number: K033583
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female