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

Model Number	7210-0152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
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 coil was implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies neurological deficits as potential complications associated with use of the device.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00237 and mfr report# 2032493-2018-00238.
Event or Problem Description
It was reported that an uneventful balloon assisted coiling procedure for a ruptured right posterior communicating artery aneurysm was performed on a patient that presented with sudden headache, reduced conscious level, and subarachnoid hemorrhage.Post procedure, the patient woke up with ipsilateral 3rd nerve palsy.The condition did not improve with a short course of steroids, and the patient underwent neurosurgical nerve decompression two (2) days later, which was believed to be a result of an immediate mass effect of the coiled aneurysm on the 3rd nerve.The patient is enrolled in a post-market clinical trial.

• Brand Name: HYDROSOFT ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8049352
• Report Number: 2032493-2018-00239
• Device Sequence Number: 11209448
• Product Code: HCG
• UDI-Device Identifier: 00816777023025
• UDI-Public: (01)00816777023025(11)171027(17)220930(10)17102755Q
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 7210-0152
• Device Lot Number: 17102755Q
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/07/2018
• 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: 70 YR