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 2020-02-20 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.
[180397197]
Age at time of event: 18 years or older. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180397198]
It was reported that the distal tip was broken. The target lesion was located in the internal carotid artery. A 190cm filterwire ez was selected for use. Upon preparation, it was noted that the distal tip of the device was broken when tried to take it out from the hoop for set-up. The procedure was continued and completed using another device and the filterwire was claimed to be defective. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01712 |
| MDR Report Key | 9732758 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-11-08 |
| Date Added to Maude | 2020-02-20 |
| 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 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 |
| Generic Name | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
| Product Code | NTE |
| Date Received | 2020-02-20 |
| Model Number | 44150 |
| Catalog Number | 44150 |
| Lot Number | 0024738253 |
| 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 | 2020-02-20 |