MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-27 for CROSSER CTO RECANALIZATION DEVICE S6 CRUS6A manufactured by Bard Peripheral Vascular, Inc..
| Report Number | MW5091367 |
| MDR Report Key | 9391839 |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-11-13 |
| Date Added to Maude | 2019-11-29 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSSER CTO RECANALIZATION DEVICE S6 |
| Generic Name | CATHETER FOR CROSSING TOTAL OCCLUSIONS |
| Product Code | PDU |
| Date Received | 2019-11-27 |
| Model Number | CRUS6A |
| Catalog Number | CRUS6A |
| Lot Number | GFDP3807 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-27 |