MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HERCULES III; UNIVERSAL STABILIZER ARM

Model Number	T401161
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Myocardial Contusion (1763); Injury (2348)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo has received 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.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
Event or Problem Description
The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, an abrasion was discovered on the heart.Per user facility the distal end/ lip of the unit was sharp/ abrasive and it rubbed and created an abrasion on the heart.There was a delay for less than a minute; product was changed out; procedure was completed successfully.
Event or Problem Description
There was a 15 minutes delay.Product was not changed out.
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 july 12, 2018.(b)(4).The returned sample was visually inspected upon receipt, and the investigation verified damage to the distal end of the hercules iii arm where the attachments are connected.A retention sample is not applicable for this is individually serialized and released for distribution.All hercules universal stabilizer arms are visually inspected for damage prior to release; therefore, it is likely that the unit was exposed to a shock force after manufacturing that caused the abrasive edge.It was not able to be determined how or when the damage occurred.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERCULES III
• Common Device Name: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7683321
• Report Number: 1124841-2018-00138
• Device Sequence Number: 16305032
• Product Code: MSW
• UDI-Device Identifier: 00699753450493
• UDI-Public: (01)00699753450493
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 02/01/2020
• Device Model Number: T401161
• Device Catalogue Number: N/A
• Device Lot Number: T00255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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