MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	7110-0204-3D-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that several attempts were made to detach the coil; however, the coil did not detach.During removal, approximately 3cm of the coil unexpectedly detached.The coil was then advanced and implanted in the intended area with a guidewire.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The pusher was returned for evaluation; however the implant coil was not attached to the pusher and was not returned.The introducer and v-grip were not returned.The strain relief on the distal heater coil section appeared burnt.The gold connector had a kink on epoxy (e3) joint.Resistance of the system was measured, and noted to be in conformance.The pusher was broken at the pet transition.The attachment tether was removed from within the body coil to expose the kind of detachment the device underwent.Since the monofilament had a mushroom and had a rebound of 0.180', it indicated a thermal detachment investigation of the device confirmed there was a thermal detachment of the implant coil, although it was reported that the coil did not initially detach.There were no discrepancies noted on the device, and other than the detached coil, the device was in specification.A root cause for the unexpected detachment cannot be determined, as conditions of use cannot be recreated in the laboratory setting and the coil was already detached from the pusher upon return.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7100010
• Report Number: 2032493-2017-00325
• Device Sequence Number: 16433296
• Product Code: HCG
• UDI-Device Identifier: 00816777025388
• UDI-Public: (01)00816777025388(11)170824(17)220731(10)1708241W9
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 07/31/2022
• Device Model Number: 7110-0204-3D-A2
• Device Lot Number: 1708241W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1