MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for ANGIODYNAMICS 45759 manufactured by Navilyst Medical, Inc..
[174869655]
Elderly male with end stage renal disease and on dialysis, while having a heart catheter "mini stick max micropuncture wire sheared off into patient's right groin when accessing vein. Doctor was able to snare wire. Wire was retrieved successfully under fluoroscopy. No complications present for the patient. " "patient had thick skin. We tried get micro-puncture access which was successful. However, couldn't get the micropuncture sheath over the wire. We tried to abort the access by taking out wire and noticed micropuncture wire broke with embolized piece in the right femoral vein, held in place with manual pressure on the groin. We took access in the right internal jugular vein and tried to snare the wire, which was unsuccessful and later took access in the left cfv and successfully snared the wire out".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9586054 |
| MDR Report Key | 9586054 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-23 |
| Report Date | 2019-12-24 |
| Date Reported to FDA | 2019-12-24 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | 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 |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-01-14 |
| Model Number | 45759 |
| Catalog Number | 45759 |
| Lot Number | 5534700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL, INC. |
| Manufacturer Address | 26 FOREST ST MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |