MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-29 for PHOTOFIX PATCH - 0.8CM X 8CM PFP0.8X8 manufactured by Cryolife, Inc..
[109409924]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[109409925]
According to an email on (b)(6) 2018: "patch was bleeding after closure of carotid. "an email was forwarded from the surgeon on (b)(6) 2018 stating, "i [surgeon] sowed the patch with the rough side down. When i did the completion duplex the was a large front of material coming off the patch. I had to re-open the patch to deal with it. Patient did fine in the end. " on 05/11/2018, a phone call was held with the surgeon to obtain additional information regarding the event reported on (b)(6) 2018. The surgeon received questions ahead of time from the manufacturer and was asked to elaborate on what he observed. According to the surgeon, he completed one wall of the carotid and then went to sew the other wall. He placed the patch with the rougher side on the luminal side. On the secondary side, the patch seemed to be soft and fibrous material on the patch. He stated the rough surface was coming a little bit loose but it was not complete dehiscence. He sewed it in and saw something hanging across the vessel when he used the duplex. Duplex gives great definition so it was not necessarily a large piece. He opened the patch and he could not pick up a piece that was the front coming off. He opened it up enough and there was nothing on the artery either. He cut the patch up the middle and then plicated the patch with a central stitch. He reattached the patch, then everything was fine and the repeat duplex did not show any front. The location of the material in question was close to the tapered end but not exactly at the tapered end. The patient is fine and did not have any complications with the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00018 |
| MDR Report Key | 7549552 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-29 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-04-26 |
| Date Facility Aware | 2018-04-30 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 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 | PHOTOFIX PATCH - 0.8CM X 8CM |
| Generic Name | INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED |
| Product Code | PSQ |
| Date Received | 2018-05-29 |
| Model Number | PFP0.8X8 |
| Catalog Number | PFP0.8X8 |
| Lot Number | 34030918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Other | 2018-05-29 |