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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL EMBOLIZATION COIL

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MICROVENTION, INC. HYDROFRAME FRAMING COIL EMBOLIZATION COIL Back to Search Results
Model Number 100619HFRM-V-A1-CN
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2017
Event Type  malfunction  
Manufacturer Narrative
The pusher was returned for analysis. Investigation analysis revealed the resistance of the system to be within specification, and passed the 4 way (angular) v-grip continuity test. The strain relief was noted to be folded and shrunk. The attachment tether had a stretched tail and a rebound length of 0. 059", indicating the device experienced forces that exceeded its specification. The implant coil was not returned for evaluation, and there are no signs of damage on the pusher. Based on the investigation and provided information, the complaint can be confirmed. The specific root cause of this complaint is unknown; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.
 
Manufacturer Narrative
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. A lot history trending review was performed and there were no similar complaints for this lot number. The device has not yet been returned for evaluation. The investigation is currently underway.
 
Event Description
It was reported that an embolization coil unexpectedly detached in the aneurysm without use of the controller. Both segments of the coil were removed from the patient. There was no reported intervention or patient injury. The patient's status is reported to be fine.
 
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Brand NameHYDROFRAME FRAMING COIL
Type of DeviceEMBOLIZATION COIL
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise drive
aliso viejo CA 92656
Manufacturer Contact
debby callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key6875987
MDR Text Key248374435
Report Number2032493-2017-00236
Device Sequence Number1
Product Code HGC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K090357
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model Number100619HFRM-V-A1-CN
Device Lot Number170303F9
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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