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 2019-02-06 for FILTERWIRE EZ 7577 manufactured by Boston Scientific Corporation.
[135335972]
It was reported that the filter basket separated from the wire and was stented inside the patient's body. The target lesion was located in the saphenous vein graft (svg) to distal right coronary artery. During a percutaneous coronary intervention procedure a 190cm filterwire ez was prepped and delivered into the target lesion, two synergy stents were deployed in the distal and proximal segments of the svg. Subsequently, the stent delivery balloon system came in contact with the proximal collar of the filterwire upon positioning of the distal stent. The retrieval sheath was then inserted into the svg after both stents were placed; however, as the sheath was being delivered, the guide catheter disengaged from the svg and the filter basket was withdrawn, unsheathed, through both stents. Consequently, the filter basket separated from the filterwire and the remaining portion of the device and sheath were then removed from the patient's body leaving the filter basket at the ostium of the svg. Snaring was attempted to retrieve the basket; however, the basket was driven through the proximal and distal stents. The basket was then deliberately pushed beyond the distal stent where a third stent was deployed and used to press the basket into the svg wall where it remained. The procedure was completed with the device. The patient tolerated the entire event without complications and left the facility immediately post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-00830 |
| MDR Report Key | 8313599 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-06 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-03-02 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2019-02-06 |
| 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 | 2019-02-06 |
| Returned To Mfg | 2019-01-31 |
| Model Number | 7577 |
| Catalog Number | 7577 |
| Lot Number | 0021641732 |
| 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 | 1. Required No Informationntervention | 2019-02-06 |