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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
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BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION Back to Search Results
Model Number 44150
Device Problems Material Integrity Problem (2978); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was noted that the filter basket was damaged.The target lesion was located in the internal carotid artery.A 190cm filterwire ez was selected for use and prepared.During the procedure, it was noted that the filter basket was damaged and it was not opposing the vessel wall when deployed.The polyurethane basket did not open completely.The device was completely removed and was re captured with filter wire retrieval catheter.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was stable.
 
Event Description
It was noted that the filter basket was damaged.The target lesion was located in the internal carotid artery.A 190cm filterwire ez was selected for use and prepared.During the procedure, it was noted that the filter basket was damaged and it was not opposing the vessel wall when deployed.The polyurethane basket did not open completely.The device was completely removed and was re captured with filter wire retrieval catheter.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was stable.
 
Manufacturer Narrative
Age at time of event: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The returned device is highly damaged and several kinks were found on the corewire.Additionally, the retrieval sheath has several kinks and is twisted.The strip tip is damaged (bent, curvy and stretched).Dimensional inspection of the device that could be measured were performed and were within specifications.
 
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Brand Name
FILTERWIRE EZ
Type of Device
TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8687361
MDR Text Key147610299
Report Number2134265-2019-06690
Device Sequence Number1
Product Code NFA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/22/2019
Device Model Number44150
Device Catalogue Number44150
Device Lot Number0021041991
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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