MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-04 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.
[137705819]
Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10
[137705820]
It was reported that the filterwire broke and had to be removed with snare. The target lesion was located in the non-calcified carotid artery which had a significant bend. A 190cm filterwire ez was selected for use. During withdrawal resistance was encountered. It was then noted that the device broke. Consequently, the whole system was removed with the help of a snaring device. The procedure was completed with another device. No further patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-01902 |
| MDR Report Key | 8386743 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-03-04 |
| 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 PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILTERWIRE EZ |
| Generic Name | TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION |
| Product Code | NFA |
| Date Received | 2019-03-04 |
| Model Number | 44150 |
| Catalog Number | 44150 |
| Lot Number | 21184538 |
| 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 | 2019-03-04 |