MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for ANGIODYNAMICS MINI STICK MAX H965457590 45-759 manufactured by Angiodynamics.
[179786015]
While attempting to gain access with the angiodynamics mini stick max catheter, the floppy end of the wire broke off in the pt's arm. A cutdown of the pt's arm was required to retrieve the wire. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093000 |
| MDR Report Key | 9711397 |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-30 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| 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 | 2020-02-13 |
| Model Number | H965457590 |
| Catalog Number | 45-759 |
| Lot Number | 5557204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | FORT WATSON BEACH FL 32548 US 32548 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |