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 2019-05-03 for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM manufactured by Boston Scientific Corporation.
[143970157]
It was reported that the device became stuck on the wire. A filterwire embolic protection system and jetstream atherectomy catheter were selected for use during a atherectomy procedure in the superficial femoral artery (sfa). While the devices were near the adductor canal it became stuck to each other. The devices were removed together. The procedure was completed with a balloon. There was no consequence to the patient, and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-04781 |
| MDR Report Key | 8577720 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-03 |
| 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 | 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 CORPORATION |
| Manufacturer Street | 2546 FIRST STREET, PROPARK |
| Manufacturer City | EL COYOL 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 | 2019-05-03 |
| 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 | 2019-05-03 |