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

Model Number	7110-0202-3D-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 was returned with the pusher in two (2) pieces.The proximal end of the device remained in the dispenser coil.The pusher was severed distal of the pet transition zone.The stretch resistance wire knot was intact at both the proximal and distal knot sections.The implant coil remained intact.Based on the available information and evaluation of the returned device, the reported complaint for broken pusher can be confirmed.The wire used as an internal stretch resistance member was broken during use.It is possible that the force exerted during use exceeding the tensile stretch of the stretch resistance member, as evidenced by retraction of the pusher body coils that were stretched and broke, separating the pusher into two (2) pieces; however, the root cause cannot be determined.
Event or Problem Description
It was reported that treatment was performed on a 3mm anterior communicating artery aneurysm via the right internal carotid artery.An embolization coil was advanced quickly through the microcatheter without use of fluoroscopy and a slight "pop" was noted.Under fluoroscopy, the coil was found to have deployed in the aneurysm without use of the controller.As the pusher was retracted, the coil implant and distal pusher did not move.The proximal half of the pusher was removed from the microcatheter and it was noted to be fractured.The non-detached coil implant and fractured distal end of the pusher was carefully removed along with the microcatheter.All components of the coil were removed from the patient without incident.There was no reported intervention or patient injury.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6577541
• Report Number: 2032493-2017-00119
• Device Sequence Number: 640572
• Product Code: HCG
• UDI-Device Identifier: 00816777025364
• UDI-Public: (01)00816777025364(11)170401(17)220331(10)170401W9
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 7110-0202-3D-A2
• Device Lot Number: 170401W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 74