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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 INC. SPIDERFX; EMBOLIC PROTECTION DEVICE
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EV3 INC. SPIDERFX; EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number SPD2-US-060-320
Device Problems Looping (1370); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
Patient Problems Chemical Exposure (2570); Vascular Dissection (3160)
Event Date 08/30/2017
Event Type  Injury  
Event Description
While opening the l brachial artery using a 6.0 spider wire for cannulation, the procedure was complicated by entanglement of the filter wire, which caused injury to the left brachial artery.This was corrected immediately without further complications to the pt.
 
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Brand Name
SPIDERFX
Type of Device
EMBOLIC PROTECTION DEVICE
Manufacturer (Section D)
EV3 INC.
4600 nathan lane
north plymouth MN 55442 2920
MDR Report Key6883476
MDR Text Key87020844
Report Number6883476
Device Sequence Number1
Product Code NFA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/19/2019
Device Model NumberSPD2-US-060-320
Device Catalogue NumberSPD2-US-060-320
Device Lot NumberA494345
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2017
Distributor Facility Aware Date08/30/2017
Device Age NA
Event Location Hospital
Date Report to Manufacturer09/14/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight57
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