MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-27 for ATLAS POSITIONER ATTACHMENT T401261 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[106749397]
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.
Patient Sequence No: 1, Text Type: N, H10
[106749398]
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.
Patient Sequence No: 1, Text Type: D, B5
[112899792]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124841-2018-00067 |
| MDR Report Key | 7468738 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-27 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-06-27 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CATHLEEN HARGREAVES |
| Manufacturer Street | 125 BLUE BALL ROAD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATLAS POSITIONER ATTACHMENT |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | DTZ |
| Date Received | 2018-04-27 |
| Model Number | T401261 |
| Catalog Number | N/A |
| Lot Number | 00065 |
| ID Number | (01)00699753450622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Brand Name | ATLAS POSITIONER ATTACHMENT |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | MSW |
| Date Received | 2018-04-27 |
| Model Number | T401261 |
| Catalog Number | N/A |
| Lot Number | 00065 |
| ID Number | (01)00699753450622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-27 |