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

Model Number	7110-0308-3D-A2
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
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.The device was not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that during balloon-assisted coil embolization of an acomm aneurysm, the implant coil did not detach and during withdrawal, the coil stretched and then detached in the microcatheter.The microcatheter was retracted; however, the coil was not able to be fully captured with the microcatheter.Attempts were made with a snare device to retrieve the coil, but they were unsuccessful and the coil advanced to the mca bifurcation.A stentriever was used to successfully remove the detached coil.There was no reported patient injury.

• 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: 8818874
• Report Number: 2032493-2019-00173
• Device Sequence Number: 2484707
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)190213(17)240131(10)1902131W6
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070656
• 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): 06/24/2019

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 7110-0308-3D-A2
• Device Catalogue Number: 7110-0308
• Device Lot Number: 1902131W6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• 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
• Patient Age: 43 YR