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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 NEUROVASCULAR HYPERFORM OCCLUSION BALLOON SYSTEM
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EV3 NEUROVASCULAR HYPERFORM OCCLUSION BALLOON SYSTEM Back to Search Results
Model Number 104-4415
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2014
Event Type  malfunction  
Event Description
Treatment of an aneurysm.On (b)(6) 2014, the patient underwent balloon assisted coiling embolization treatment.During preparation it was reported that the balloon burst.A new balloon was successfully prepared and used to complete the procedure.No patient injury was reported as a result of the procedure.
 
Manufacturer Narrative
The catheter was returned for evaluation without the guidewire as it was discarded.The balloon was found to be ruptured between the marker bands.The evaluation could not determine the cause of the event.(b)(4) = balloon rupture.(b)(4).
 
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Brand Name
HYPERFORM OCCLUSION BALLOON SYSTEM
Type of Device
OCCLUSION BALLOON SYSTEM
Manufacturer (Section D)
EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
henry to
9775 toledo way
irvine, CA 92618
9496801335
MDR Report Key3892014
MDR Text Key4653493
Report Number2029214-2014-00364
Device Sequence Number1
Product Code MJN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 05/25/2014
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
Device Operator Physician
Device Expiration Date08/13/2015
Device Model Number104-4415
Device Lot Number9683400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2014
Initial Date FDA Received06/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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