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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANEURYSM CLIP

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ANEURYSM CLIP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Loss of consciousness (2418)
Event Date 02/16/2018
Event Type  Injury  
Event Description
The reporter states the pt came in for a routine mri and had stated that she had no devices implanted as well as no brain and heart surgeries prior.Once the pt laid down on the mri table, the mri technologist went to get ear plugs and upon return discovered the pt unresponsive on the table.The technologist rolled out the bed with the pt in it and activated the emergency response code and that's when the emergency doctors came.The drs found a carotid pulse and called for a ct study where they found the pt had an aneurysm clip placed and a brain bleed in a different location in the brain.The reporter had the neurological team observe the case and didn't believe the clip had anything to do with the event.
 
Event Description
Add'l info received from reporter for report mw5075442, on 07/13/2018.Reporter stated she would like her company name ((b)(6)) included in her reporter info.
 
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Brand Name
ANEURYSM CLIP
Type of Device
ANEURYSM CLIP
MDR Report Key7289224
MDR Text Key100892920
Report NumberMW5075442
Device Sequence Number1
Product Code HCH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age78 YR
Patient Weight55
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