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 2019-05-15 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.
[145097649]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145097650]
It was reported that the filterwire fractured. A 190cm filterwire ez was selected for use for a saphenous vein graft (svg) percutaneous coronary intervention for bypass in a stenosed target lesion. When attempting to set up the filterwire, the device was stuck within the non-bsc guide catheter. The physician attempted to pull out the filterwire, but the device broke. The filterwire was then pulled out with the guiding catheter and there were no pieces of the device left inside the patient. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05233 |
| MDR Report Key | 8611608 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2018-09-14 |
| Date Added to Maude | 2019-05-15 |
| 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 CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION |
| Product Code | NFA |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-08 |
| Model Number | 44150 |
| Catalog Number | 44150 |
| Lot Number | 0022655075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-15 |