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

Model Number T401261

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 04/05/2018

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). Results pending completion of evaluation conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during the use of the device for cardiopulmonary bypass, the positioner caused 2 centimeter laceration between the layer of fat of cardiac apex and myocardial layer. The laceration was treated by taking a piece of pericardium and sewing it over the area in the form of a patch. There was approximately one hour delay at the end of the procedure to repair the area. It was also reported that the vacuum was set at 30 kpa which is equal to approximately 225 mmhg, still within the limit of 250 mmhg. There was blood loss of less than 100 ml. Product was not changed out. Procedure was completed successfully.

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 apr 27, 2018. The sample was not returned for evaluation nor were any pictures provided; therefore, a thorough investigation could not be performed and a definitive root cause can not be determined. A retention sample from the affected product code/lot number was obtained and visually inspected. No sharp edges or burrs were noted on the cone or anywhere else on the device. The suction test was performed on the retention sample. It was able to provide the suction to the silicone test block, lift it up from the surface and release the suction upon opening the blue vacuum stopcock to the atmosphere. No anomalies were noted when releasing the retention sample from the test silicone block. To replicate the reported event, the suction test was performed again, this time an attempt was made to release the silicone block without turning the blue stop cock to the atmosphere. During this effort it was difficult to release the suction cup from the silicone block. With the reported injury occurring at the end of use, the most likely root cause could be the positioner may have been removed from the heart prior to opening the vacuum stopcock to the atmosphere. Another possible root cause could be the patient's medical condition resulted in increased fragility of the cardiac tissue. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: ATLAS POSITIONER ATTACHMENT
• Type of Device: UNIVERSAL STABILIZER ARM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7468738
• MDR Text Key: 106749397
• Report Number: 1124841-2018-00067
• Device Sequence Number: 0
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: T401261
• Device Catalogue Number: N/A
• Device Lot Number: 00065
• Other Device ID Number: (01)00699753450622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2018 Patient Sequence Number: 1