MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL

Model Number	100206H2HS-V
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	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 returned to the manufacturer was found to have the implant coil attached to the pusher, which was inconsistent with the reported details.It was determined that the returned device was not associated with the reported complaint.The actual device used for the procedure was not returned for analysis; therefore, the root cause cannot be determined.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 re-positioning of the coil in the aneurysm, the coil detached without use of the controller.The coil remains implanted in the aneurysm.There was no reported intervention or patient injury as a result of the issue.The patient was reported to be okay.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7979388
• Report Number: 2032493-2018-00219
• Device Sequence Number: 19115600
• Product Code: HCG
• UDI-Device Identifier: 00816777022899
• UDI-Public: (01)00816777022899(11)180425(17)230331(10)1804251W4
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 100206H2HS-V
• Device Lot Number: 1804251W4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 73