MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-12 for HERCULES III T401161 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[113868311]
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.
Patient Sequence No: 1, Text Type: N, H10
[113868312]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2018-00138 |
| MDR Report Key | 7683321 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-12 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | DTZ |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-07-03 |
| Model Number | T401161 |
| Catalog Number | N/A |
| Lot Number | T00255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | MSW |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-07-03 |
| Model Number | T401161 |
| Catalog Number | N/A |
| Lot Number | T00255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-07-12 |