MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-01-16 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[5283394]
According to the report, the patient had adjunctive tmr. The complainant heard that the patient had a poor outcome; there is a possibility of a death. The patient was operated on by the complainant's partner.
Patient Sequence No: 1, Text Type: D, B5
[5575081]
According to the report, the patient had adjunctive tmr. The complainant heard that the patient had a poor outcome; there is a possibility of a death. The patient was operated on by the complainant's partner.
Patient Sequence No: 1, Text Type: D, B5
[12850288]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[13058290]
According to the report from the representative, the patient had adjunctive tmr. The complainant heard that the patient had a poor outcome; there is a possibility of a death. The patient was operated on by the complainant's partner. Multiple attempts were made via email on (b)(6) 2014, (b)(6) 2015 to clarify the nature of the poor outcome, but were not successful. The representative contacted the surgeon on (b)(6) 2015, but the surgeon declined to provide specific outcomes related to the patient. A request for information letter was mailed to the surgeon on (b)(6) 2015, but a response was not received. Additional information received via phone contact with the representative on (b)(6) 2015 indicated that the date of procedure and the date of incident was (b)(6) 2014. The lot number ta-0434 was provided for the hp-sg3 handpiece that was used in the procedure. There is no evidence of a root cause to this complaint in the manufacturing or incoming inspection records for lot ta-04034. According to all documentation the handpieces were built to specification, underwent all final testing and inspections and were appropriately sterilized. A review was performed based on the available information. There is insufficient information to determine what the reported "poor outcome" actually was, or how the device was utilized during the procedure. Therefore, no conclusion can be made regarding the relationship between the reported event and the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2015-00003 |
| MDR Report Key | 4428818 |
| Report Source | 06,07 |
| Date Received | 2015-01-16 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-10-30 |
| Date Mfgr Received | 2014-12-19 |
| Date Added to Maude | 2015-01-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| 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 | TRANSMYOCARDIAL REVASCULARIZATION HANDPIECE |
| Product Code | MNO |
| Date Received | 2015-01-16 |
| Model Number | HP-SG3 |
| Operator | PHYSICIAN |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Death; 2. Other | 2015-01-16 |