MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TITAN STABILIZER ATTACHMENT; UNIVERSAL STABILIZER ARM

Model Number	T401231
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, 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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, while using the titan stabilizer, the right metal wishbone part of the footplate rubbed a hole in the heart.A hemostatic agent was used to stop the bleeding.There was approximately 100 ml of blood loss, there was minimal delay, the product was not changed out, the surgery 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, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 3259, 12).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 12 - cause traced to device design.The affected sample was inspected and observed that the u shaped tube was broken within the area of the silicone foot.The remaining metal tube was removed from the silicone foot where it was observed that the tube was bent.The tube was measured as.070" od, this is within design specification.The u-tube is meant to be bent, however, bending past design specification can lead to breakage.A representative retention sample was evaluated.The u shaped tube was measured at various points between.070" -.072", 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* to -20*.The retention was bent in this way and did not break.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: TITAN STABILIZER ATTACHMENT
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9679645
• Report Number: 1124841-2020-00021
• Device Sequence Number: 2837370
• Product Code: MWS
• UDI-Device Identifier: 00699753450554
• UDI-Public: (01)00699753450554
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2020

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: 09/10/2021
• Device Model Number: T401231
• Device Catalogue Number: N/A
• Device Lot Number: 00107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/30/2020; 03/10/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/17/2020; 03/12/2020
• 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: Other; Required Intervention