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

Model Number	100306HFRM-V-3D-A2
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The implant coil remains in the patient and the pusher was discarded at the user facility, therefore, a device analysis could not be performed and the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature, and difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during deployment of an embolization coil, the coil would not detach.During withdrawal, the coil detached in the microcatheter.The coil was pushed into the aneurysm with the guide wire.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 92656
• MDR Report Key: 10909757
• Report Number: 2032493-2020-00352
• Device Sequence Number: 2885216
• Product Code: HCG
• UDI-Device Identifier: 00816777026576
• UDI-Public: (01)00816777026576(11)200514(17)250430(10)2005145W6
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 04/30/2025
• Device Model Number: 100306HFRM-V-3D-A2
• Device Catalogue Number: 100306HFRM-V
• Device Lot Number: 2005145W6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1