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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFAME FRAMING COIL; EMBOLIZATION COIL
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MICROVENTION, INC. HYDROFAME FRAMING COIL; EMBOLIZATION COIL Back to Search Results
Model Number MV-80931HHF
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2014
Event Type  malfunction  
Event Description
Coiling treatment was conducted of an aneurysm.It was reported that during coil deployment, the coil prematurely detached in the microcatheter prior to being inserted into the aneurysm.The implant coil was successfully removed with the microcatheter.No injury was reported with the pt as a result of the procedure.
 
Manufacturer Narrative
Sample analysis: the device involved in the event will not be returned for evaluation as it was reported discarded.(b)(4).
 
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Brand Name
HYDROFAME FRAMING COIL
Type of Device
EMBOLIZATION COIL
Manufacturer (Section D)
MICROVENTION, INC.
tustin CA
Manufacturer Contact
teri halverson
1311 valencia
tustin, CA 92780
7142478000
MDR Report Key4349328
MDR Text Key5200854
Report Number2032493-2014-00106
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/16/2018
Device Model NumberMV-80931HHF
Device Lot NumberP130116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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