MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for ANGIODYNAMICS MINI STICK MAX REF 45-759 manufactured by Navilyst Medical, Inc. / Angiodynamics, Inc..
[174669026]
Fracture of mini stick max during lead change out. Wire had to be snared to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092150 |
| MDR Report Key | 9575621 |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-20 |
| Date Added to Maude | 2020-01-10 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIODYNAMICS MINI STICK MAX |
| Generic Name | DILATOR, VESSEL FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-01-09 |
| Model Number | REF 45-759 |
| Lot Number | 5530160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |