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 2017-03-01 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[68750923]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[68750924]
According to the report, "subject (b)(6) presented to the ed on (b)(6) 2017 with sharp chest pain. Cardiology was consulted and they determined that it was likely musculoskeletal in nature related to the cabg procedure that he had done at the time of the tmr. They did an ekg and nothing changed from the prior one. He was not admitted. "
Patient Sequence No: 1, Text Type: D, B5
[74718108]
According to the case report forms (crfs) and report, the patient presented to the ed (emergency department) on (b)(6) 2017 with sharp chest pain. Cardiology was consulted and they determined it was likely musculoskeletal in nature related to the cabg. An ekg was performed and showed no changes from the prior one. The manufacturing records were reviewed for handpiece ta-04094. It was confirmed that all records were controlled, available for review, and met all specifications per the device master record. This (b)(6) male patient underwent tmr + cabg via sternotomy with concomitant endovein harvest while on cardiopulmonary bypass on (b)(6) 2016. The patient? S medical history was significant for a preoperative eg of 40%, diabetes, previous myocardial infarction (non-st segment elevation myocardial infarction/non q-wave within 2 weeks of tmr procedure), hypertension, hepatitis c, severe multi-vessel coronary artery disease with poor quality targets, and smoking. ? The total procedure time was 225 minutes, with 76 minutes spent on cardiopulmonary bypass. A total of 37 tmr channels were placed in the following locations: 8 anterolateral, 8 posterolateral, 8 inferior and 13 anterior. Tmr was performed before the cabg procedure, in which 4 grafts were placed to the following target vessels (1 to each location): left internal mammary artery to left anterior descending artery (lad); saphenous vein graft to diagonal; saphenous vein graft to large intramyocardial ramus; saphenous vein graft to right posterior descending artery. The patient was discharged on (b)(6) 2017 (pod 6).? According to medical records provided by the site, cardiology was consulted to evaluate the patient and a chest x-ray was performed which was unchanged from x-ray obtained on (b)(6) 2017 after the tmr +cabg procedure. The patient? S chest pain was determined to be musculoskeletal pain associated with recent open heart surgery. The patient did not require admission and was discharged from the ed.? Thirty-day follow-up was performed on (b)(6) 2017; the patient reported no angina.? The cause of the patient? S chest pain was determined to be musculoskeletal pain related the patient? S recent sternotomy associated with open heart surgery, and is not likely related to the tmr procedure.
Patient Sequence No: 1, Text Type: N, H10
[74718109]
According to the initial report, the patient presented to the hospital on (b)(6) 2017 with complaints of sharp chest pain. Cardiology was consulted and they determined that it was likely musculoskeletal in nature related to the cabg procedure performed at the time of the? Transmyocardial revascularization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00008 |
| MDR Report Key | 6367938 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-02 |
| Date Added to Maude | 2017-03-01 |
| 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 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 | 2017-03-01 |
| Model Number | HP-SG3 |
| Lot Number | TA-04094 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-03-01 |