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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number H74939293054030
Medical Device Problem Code Premature Activation (1484)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that inadvertent stent deployment occurred.During preparation of an 5 x40 x130 innova¿, a.35mm non bsc wire became entrapped on the stent and inadvertently the stent deployed.Another stent was selected for use to complete the procedure.No patient complications were reported and the patients status is fine.
 
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Brand Name
INNOVA¿
Common Device Name
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key6486036
Report Number2134265-2017-03369
Device Sequence Number11085144
Product Code NIP
UDI-Device Identifier08714729873907
UDI-Public(01)08714729873907(17)20190531(10)19238816
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P140028
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) 03/22/2017
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 Date05/31/2019
Device Model NumberH74939293054030
Device Catalogue Number39293-05403
Device Lot Number19238816
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2017
Initial Report FDA Received Date04/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE - TERUMO 035 ADVANTAGE GLIDEWIRE
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