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 2020-03-23 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.
[184496077]
It was reported that there was difficulty retrieving the filter. The mildly tortuous stenosed target lesion was located in the mid and distal of right coronary artery (rca). After the physician delivered a 190 cm filterwire ez to the distal rca, a 4. 00x48mm synergy ii drug-eluting stent was deployed to the mid and distal of rca. Following stent deployment and post dilatation, the physician delivered retrieve sheath to pull back the filter wire but the sheath was unable to reach the filter. As the physician pulled back the wire, the deployed stent became deformed and the filter wire become stuck in the stent. Then, a 7fr guidezilla guide extension catheter was advanced to remove the filterwire but was unsuccessful. Finally, the patient was sent to surgery. Surgery was performed to remove the stent and the filterwire. Coronary artery bypass graft surgery was also completed. Post surgery, the patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2134265-2020-03699 |
MDR Report Key | 9865906 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-03-23 |
Date of Report | 2020-03-23 |
Date of Event | 2020-03-18 |
Date Mfgr Received | 2020-03-18 |
Device Manufacturer Date | 2019-08-19 |
Date Added to Maude | 2020-03-23 |
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 CORPORATION |
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 | 2020-03-23 |
Model Number | 44150 |
Catalog Number | 44150 |
Lot Number | 0024290802 |
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 | 2020-03-23 |