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

Model Number T401161

Device Problem Scratched Material (3020)

Patient Problems Myocardial Contusion (1763); Injury (2348)

Event Date 06/15/2018

Event Type  Injury  

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 Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the distal end of the hercules arm is sharp and abrasive which caused an abrasion in the heart while doing the procedure.There was a about a 15 minute delay to repair the abrasion.The procedure was completed successfully using the same arm as it was fixed by putting a seal on the unit.*no blood loss, *product was not changed out, *procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.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 an 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.

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 02, 2018.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HERCULES III
• Type of Device: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7656811
• MDR Text Key: 112992882
• Report Number: 1124841-2018-00130
• Device Sequence Number: 0
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention