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

Model Number	T401261
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
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
During a performance survey the user facility reported to terumo cardiovascular that they stop using the atlas positioner because it frequently tears the epicardium making it difficult to fix the bleeding.No other information about the nature of the event was provided.
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 march 9, 2020.Upon further investigation of the reported event, the following: g4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes).H6 (identification of evaluation codes 4114, 3221, 4315).Method code #1: 14114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The sample was not returned so a direct investigation could not be performed.Past product complaints were reviewed for similar issues.A root cause cannot be determine as the lot number and device were not returned.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: ATLAS POSITIONER ATTACHMENT
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9808680
• Report Number: 1124841-2020-00057
• Device Sequence Number: 14204029
• Product Code: MWS
• UDI-Device Identifier: 00699753450622
• UDI-Public: (01)00699753450622
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Model Number: T401261
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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