MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100206HFRM-V-3D-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
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 analysis.The root cause cannot be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that balloon-assisted coiling was performed for an middle cerebral artery (mca) bifurcation aneurysm.During placement of the third coil, resistance was encountered and during the attempt to remove the coil, it detached in the microcatheter.Both segments of the coil were removed together with the microcatheter.There was no reported patient injury or additional intervention.

• Brand Name: HYDROSOFT 3D
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9857954
• Report Number: 2032493-2020-00071
• Device Sequence Number: 2533890
• Product Code: HCG
• UDI-Device Identifier: 00816777026514
• UDI-Public: (01)00816777026514(11)191122(17)241031(10)1911221W6
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 10/31/2024
• Device Model Number: 100206HFRM-V-3D-A2
• Device Catalogue Number: 100206HFRM-V
• Device Lot Number: 1911221W6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR