MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for COAXIAL MICROINTRODUCER KIT MINI STICK MAX 45756 45-756 manufactured by Angiodynamics, Inc. / Navilyst Medical, Inc..
[183913513]
During cardiac cath for stemi, angiodynamics mini stick max coaxial microintroducer kit used, sheath 5fx10cm, needle 70 mm echogenic, wire nitinol tungsten, ref 45-756, lot 5561860, upn (b)(4), exp 12/31/2022 used. Pt moved during the procedure and when cardiologist tried to remove wire, it became entrapped in the vessel and its fragment was dislodged in subintimal space of external iliac artery. Cardiologist unable to remove fragment. When the wire removed (the remaining wire not the fragment), it was noted the wire had became unraveled and "looked like a spring". Vascular surgery consulted regarding extraction of entrapped wire fragment, however, open surgery for retrieval not indicated. Per vascular surgeon, wire fragment is subintimal and therefore unlikely to represent an embolic source or nidus. Covered stent to the area considered but determined not to be needed. Full disclosure to family. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093777 |
| MDR Report Key | 9840252 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-08 |
| Date Added to Maude | 2020-03-17 |
| 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 | COAXIAL MICROINTRODUCER KIT MINI STICK MAX |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-03-16 |
| Model Number | 45756 |
| Catalog Number | 45-756 |
| Lot Number | 5561860 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. / NAVILYST MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |