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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL EMBOLIZATION COIL

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MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL EMBOLIZATION COIL Back to Search Results
Model Number 100154HS-V-A-CN
Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2017
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation; however, the microcatheter was not returned for analysis. The implant coil was noted to be detached from the pusher, and the proximal end was stretched and damage at the tie knot section. The lead wires were noted to be separate from the core wire. The striations on the monofilament body confirms a tensile pull. The specific root cause of this complaint is unknown, although the device exhibits evidence that the monofilament 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 did not advance in the middle of the microcatheter, then the coil unexpectedly detached in the microcatheter. 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 NameMICROPLEX HYPERSOFT HELICAL
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 Key6819648
MDR Text Key248374915
Report Number2032493-2017-00210
Device Sequence Number1
Product Code HGC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132952
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 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model Number100154HS-V-A-CN
Device Lot Number150923E2
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 Received07/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2015
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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