MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-05-17 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[108613884]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[108613885]
According to an email on 04/18/218: "presented to er (emergency room) on (b)(6) 2017 with chest pain, with radiation to arm, shortness of breath and nausea and vomiting. Chest pain was unresponsive to nitroglycerin. Morphine iv provided relief. Initial troponin was negative. Cardiac catheterization was done on (b)(6) 2017 which showed global hypokinesis with estimated ef & nbsp; (ejection faction) 50%, severe multivessel coronary artery disease, widely patient lima & nbsp; (left internal mammary artery) to distal lad (left anterior descending artery) and luxuriant wispy collateralization observed from injection of left coronary artery and right coronary artery. Mild elevation in serial troponins up to 0. 11 was felt to be due to strain and not due to ulcerated plaque occlusion. Patient was discharged on (b)(6) 2017 to be medically managed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00016 |
| MDR Report Key | 7523747 |
| Report Source | STUDY |
| Date Received | 2018-05-17 |
| Date of Report | 2018-08-15 |
| Date of Event | 2017-02-07 |
| Date Facility Aware | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-05-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD, NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOGRIP III HANDPIECE |
| Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2018-05-17 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04093 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-05-17 |