MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for STENT, CORONARY manufactured by Celonova Biosciences, Inc..
[185223638]
Stent found to be removed from the balloon when removing the stent catheter from the patient. The stent was found in the tuohy attached to the guide catheter. Stent was retrieved without any harm to patient. Patient monitored for adverse effects - no harm to patient. Whole stent was able to be removed from patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888461 |
| MDR Report Key | 9888461 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-05 |
| Report Date | 2020-03-16 |
| Date Reported to FDA | 2020-03-16 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | STENT, CORONARY |
| Product Code | MAF |
| Date Received | 2020-03-27 |
| Lot Number | 1801234001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELONOVA BIOSCIENCES, INC. |
| Manufacturer Address | 5840 EL CAMINO REAL SUITE 111 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |