MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HERC III 360; HERCULES ARM

Model Number	T401160
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
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 when they tried to attach the actual sample to a retractor, they found the retractor clamp handle of the actual device would not functioned properly.It is unknown when this event occurred or if there was a delay in the procedure.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.
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 september 27, 2019.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem, updated).D4 (additional device information, updated lot number).D10 (date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).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.
Event or Problem Description
Additional information received from the user facility that the event occurred during cardiopulmonary bypass and the event did not result in any delay.
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: d4 (additional device information - added exp date); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information and device evaluation); h3 (device evaluated by manufacturer); h4 (device manufacture date); h6 (identification of evaluation codes 10, 3331, 3259, 4307).Method code #1: 10 - actual device evaluated.Method code #2: 3331 - analysis of production records.Method code #3: 4112 - analysis of data provided by user/third party.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was inspected upon receipt and confirmed to have broken lock plates.The broken lock plates were sent to an outside laboratory for metallurgical analysis and it was determined that the fractures were brittle in the form of cleavage or intergranular on the inside of the plates with some mixed-mode brittle-ductile fracture present.The fractures are indicative of the result of single-event impact loads.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERC III 360
• Common Device Name: HERCULES ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9128591
• Report Number: 1124841-2019-00266
• Device Sequence Number: 11407201
• Product Code: MWS
• UDI-Device Identifier: 00699753450486
• UDI-Public: (01)00699753450486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2020

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 Expiration Date: 10/27/2021
• Device Model Number: T401160
• Device Catalogue Number: N/A
• Device Lot Number: T00553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 02/11/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/21/2019; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1