MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-08-25 for PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM FG-000001-09 UNK manufactured by Cardica, Inc..
[1097690]
This was a cabg case. Upon firing the cutter of the pas-port device, the physician noticed an excess of bleeding and described the size of the hole on the aorta as about the size of an index and middle finger width. The hole was circular. Physician closed the hole and hand sewed the graft in a different location. The physician noted that there was nothing very peculiar about the particular anatomy of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004114958-2009-00006 |
| MDR Report Key | 1450048 |
| Report Source | 05 |
| Date Received | 2009-08-25 |
| Date of Report | 2009-07-27 |
| Date of Event | 2009-07-27 |
| Date Mfgr Received | 2009-07-27 |
| Date Added to Maude | 2009-08-28 |
| 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 | AGATHA LAW, ASSOCIATE |
| Manufacturer Street | 900 SAGINAW DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM |
| Generic Name | CARDIOVASCULAR SURGICAL INSTRUMENT |
| Product Code | NCA |
| Date Received | 2009-08-25 |
| Model Number | FG-000001-09 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDICA, INC. |
| Manufacturer Address | REDWOOD CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-25 |