MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-31 for UNIVERSAL STABILIZER ARM, HERCULES 3 001-401-152 manufactured by Atricure, Inc..
[131787428]
(b)(4): the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the hercules device was not reported or able to be subsequently ascertained. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[131787429]
A medsun report was submitted by the facility on (b)(6) 2018 regarding a (b)(6) male patient who underwent an emergent coronary revascularization, left heart coronary and fractional flow reserve (ffr) of the ostial left anterior descending (lad) right femoral artery angiogram on (b)(6) 2018. A hercules retractor device was being used, the retractor broke and fell apart in the patient? S chest. The instrument was changed, and a new device was obtained. An x-ray was taken at the end of the case, after direct communication with the radiologist to confirm no device pieces left behind the surgeon completed the procedure and closed patient? S chest. There was no patient harm. The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00225 |
| MDR Report Key | 8207041 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-05-27 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-12-31 |
| 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 | MR. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL STABILIZER ARM, HERCULES 3 |
| Generic Name | UNIVERSAL STABILIZER ARM, HERCULES 3 |
| Product Code | DWS |
| Date Received | 2018-12-31 |
| Model Number | 001-401-152 |
| Catalog Number | 001-401-152 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-31 |