MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-05-15 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[108290174]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[108290175]
According to an email on 04/18/2018: presented to ed (emergency department) with "burning chest pain" with some nausea and vomiting over previous 2 days. Ecg (electrocardiogram) showed no st segment elevation. Started on a heparin and nitroglycerin drip which provided no relief of his chest pain. Cardiac catheterization on (b)(6) 2017 showed global hypokinesis with ef (ejection faction) 45 %, severe multi-vessel coronary artery disease, lima (left internal mammary artery) to lad (left anterior descending artery) has 50% proximal stenosis but fills the distal lad. Serial troponins were negative. Patient was discharged on (b)(6) 2017 to home. Was to follow up with cardiologist in one week to complete last of 35 total treatments of eecp (enhanced external counter pulsation).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00013 |
| MDR Report Key | 7514722 |
| Report Source | STUDY |
| Date Received | 2018-05-15 |
| Date of Report | 2018-08-14 |
| Date of Event | 2017-09-14 |
| Date Facility Aware | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-05-15 |
| 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 | 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 | 2018-05-15 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA 04093 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-05-15 |