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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL

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MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL Back to Search Results
Model Number 100208H2HS-V-A2
Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device was returned for evaluation.The pusher heater coil was observed to be compressed and deformed and the implant coil was detached; however, the root cause could not be determined.
 
Event Description
It was reported that during a coil embolization treatment of a para-opthalmic aneurysm, the coil unexpectedly detached in the hub of the microcatheter.Both segments of the coil were removed in their entirety.There was no reported intervention or patient injury.The patient's current status is reported to be fine.
 
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Brand Name
HYDROSOFT HELICAL 10 VTA
Type of Device
EMBOLIZATION COIL
Manufacturer (Section D)
MICROVENTION, INC.
1311 valencia avenue
tustin CA 92780
Manufacturer Contact
debby callahan
1311 valencia avenue
tustin, CA 92780
MDR Report Key6655099
MDR Text Key78138682
Report Number2032493-2017-00146
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00816777022905
UDI-Public(01)00816777022905(11)170412(17)220331(10)170412W4
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K080666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 05/22/2017
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 Other
Device Expiration Date03/31/2022
Device Model Number100208H2HS-V-A2
Device Lot Number170412W4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/22/2017
Initial Date FDA Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age42 YR
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