MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for AVX THROMBECTOMY SET manufactured by Boston Scientific Corporation.
[181837186]
Date of event was approximated to (b)(6) 2019 as it was reported the event happened 6+ months ago.
Patient Sequence No: 1, Text Type: N, H10
[181837187]
It was reported that the patient coded. An angiojet avx catheter was used for treatment. It was reported that the patient coded after use of the angiojet avx. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02455 |
| MDR Report Key | 9779734 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 500 COMMANDER SHEA BOULEVARD |
| Manufacturer City | QUINCY MA 02171 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02171 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVX THROMBECTOMY SET |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-03-03 |