MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for PROGLIDE PERCLOSE 12673-03 manufactured by Abbott Vascular.
[185711709]
During a transcatheter aortic valve replacement procedure, after the valve was deployed, a vascular closure device was used on the right femoral artery. The cardiologist encountered difficulty removing the device which resulted in the femoral artery needing repaired by vascular surgeon. The vascular team was consulted, and the surgeon made the repair. Blood products were given due to blood loss and patient instability. The patient was intubated during the vascular repair. The patient was transferred to icu after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902789 |
| MDR Report Key | 9902789 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-05 |
| Report Date | 2020-03-18 |
| Date Reported to FDA | 2020-03-18 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGLIDE PERCLOSE |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Model Number | 12673-03 |
| Catalog Number | 12673-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 3200 LAKESIDE DR SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-31 |