MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-17 for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM manufactured by Boston Scientific Corporation.
[145377449]
It was reported that vasospasm occurred. A. 014 guidewire was selected for used together with the filterwire for use during a stenting procedure. The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance. The stent was removed due to the guidewire advancement restriction. Angiography was performed and the patient experienced vasospasm; subsequently the filterwire was removed then the angiography was performed again. The. 014 guidewire was put in place, and the 7x40 stent was opened, however; the. 014 guidewire still could not cross the 7x30 stent. Another device was used to complete the procedure. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05421 |
| MDR Report Key | 8619799 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-17 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-05-27 |
| Date Added to Maude | 2019-05-17 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM |
| Generic Name | TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION |
| Product Code | NFA |
| Date Received | 2019-05-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2019-05-17 |