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

Model Number	7110-0256-3D-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	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not been returned to the manufacturer.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization of a pcom aneurysm, the coil was being used as a guidewire to gain access to the aneurysm.During this manipulation, the coil detached and over half of the coil was in the parent vessel.The coil was retrieved with a stentriever and an aspiration catheter.There was no reported symptoms or injuries related to the coiling or retrieval of the coil.

• 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: 8672190
• Report Number: 2032493-2019-00152
• Device Sequence Number: 2039572
• Product Code: HCG
• UDI-Device Identifier: 00816777025432
• UDI-Public: (01)00816777025432(11)181219(17)231130(10)1812195P6
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 7110-0256-3D-A2
• Device Catalogue Number: 7110-0256
• Device Lot Number: 1812195P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention