MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PROGREAT LAMBDA; MICRO CATHETER SYSTEM

Model Number	CC*M1916SN
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: procode: dqo, kra.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical corporation (tmc) (importer), registration no.(b)(4), is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer), registration no.3009500972.
Event or Problem Description
Terumo medical corporation received the following reported information: the first coil became stuck, so they took the micro out and put it back.A 2mm coil then worked.On the third coil attempt, it became stuck again.While pushing a runthrough wire, the wire perforated the catheter.They were able to take it out before the distal segment broke off.The procedure performed was an hae procedure.The estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.We investigated similar complaints that had occurred in the past.As a result, there had been no similar complaints about the production lot 250203090 in the past.However, we could not identify the occurrence cause of the following reasons.The involved device was not returned, and we couldn't perform the detailed investigation.It occurred with normal usage.Details of the occurrence situation were unknown.There have been no prior similar complaints within the same lot, and no abnormalities were identified that would indicate a potential risk of penetration due to the use of a guidewire.Terumo medical corporation (tmc) (importer), registration no.2243441, is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer), registration no.3009500972.

• Brand Name: PROGREAT LAMBDA
• Common Device Name: MICRO CATHETER SYSTEM
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehayamachi; kakamigahara; gifu, 501-6 024; JA 501-6024
• Manufacturer (Section G): TERUMO CLINICAL SUPPLY CO., LTD.; reg. no. 3009500972; 3 kawashima-takehayamachi; kakamigahara, gifu 501-6 024; JA 501-6024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24090313
• Report Number: 3009500972-2025-00026
• Device Sequence Number: 21384942
• Product Code: DQO
• UDI-Device Identifier: 04987350740984
• UDI-Public: 04987350740984
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CC*M1916SN
• Device Catalogue Number: CCM1916SN
• Device Lot Number: 250203090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Patient Sex: Unknown