MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for ANGIOJET? ZELANTEDVT? 114610-001 manufactured by Boston Scientific Corporation.
[183272029]
Elderly female with history of hypertension and type 2 diabetes. Left leg pain for 2 days, positive deep vein thrombosis. Undergoing left lower extremity percutaneous thrombectomy with angiojet and genioplasty. During the procedure, the angiojet was sucking instead of spraying tpa on the appropriate setting. Device removed without harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9828881 |
| MDR Report Key | 9828881 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-28 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | ANGIOJET? ZELANTEDVT? |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-13 |
| Model Number | 114610-001 |
| Lot Number | 24365758 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |