MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TITAN 360 STABILIZER; TITAN ULTRA STABILIZER ATTACHMENT

Model Number	T401231U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo will not receive the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the titan stabilizer broke in the middle of the procedure.There was a 15¿30-minute delay trying to fish out the broken piece that had fallen into the chest and setting up a new unit.*the product was changed out *procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on february 6, 2026.Upon further investigation of the reported event, the following information is new and/or changed: g3.(date received by manufacturer), g6.(indication that this is a follow-up report), h2.(follow-up due to additional information), h6.(identification of evaluation codes 11, 3331, 4114, 3252, 19).The affected sample was not returned; however, a photo was provided where it was observed that the u-shaped tube was broken within the area of the silicone foot.A retention sample from the same product and lot number was obtained, inspected and measured.The u-shaped tube was measured at various points between.070", this is within design specification.The design criteria for the u-shaped tube is that it must be able to withstand 3 bending cycles of +45 degrees to -20 degrees.The retention was bent in this way and did not break.Without a returned device, a thorough investigation could not be performed.Upon evaluation of the picture provided, it was found that the u-tube was broken from just inside the over mold end.The most likely root cause of this failure is over bending.The u-tube is meant to be bent, however, bending past design specification can lead to breakage.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: TITAN 360 STABILIZER
• Common Device Name: TITAN ULTRA STABILIZER ATTACHMENT
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 24280381
• Report Number: 1124841-2026-00016
• Device Sequence Number: 8569510
• Product Code: MWS
• UDI-Device Identifier: 00699753450578
• UDI-Public: (01)00699753450578(17)280819(10)00232
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: T401231U
• Device Catalogue Number: N/A
• Device Lot Number: 00232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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 Sex: Unknown