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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 7577
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/08/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the filterwire separation occurred.A 2.25mm-3.5mm 190cm filterwire ez was selected for use.During preparation, it was noted that the filterwire wire became separated.No patient complications were reported and the patient's status was stable.
 
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Brand Name
FILTERWIRE EZ
Common Device Name
TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8441002
Report Number2134265-2019-02798
Device Sequence Number11028569
Product Code NFA
UDI-Device Identifier08714729808800
UDI-Public08714729808800
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K061332
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/24/2019
Device Model Number7577
Device Catalogue Number7577
Device Lot Number0020559407
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2019
Initial Report FDA Received Date03/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age81 YR
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