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

Model Number	100208H2HS-V-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6655099
• Report Number: 2032493-2017-00146
• Device Sequence Number: 19201964
• Product Code: HCG
• UDI-Device Identifier: 00816777022905
• UDI-Public: (01)00816777022905(11)170412(17)220331(10)170412W4
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 100208H2HS-V-A2
• Device Lot Number: 170412W4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR