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

Model Number	8510-0154
Medical Device Problem Codes	Break (1069); Device Issue (2379); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation findings the complaint cannot be confirmed as the device displays evidence of thermal detachment, which is evidence of detachment via the v-grip detachment controller.It appears the coil was detached, however it was not observed by the user.The root cause could not be determined.(b)(4).
Event or Problem Description
It was reported that during the embolization treatment of an aneurysm, the coil did not detach.Upon withdrawal of the device, the coil detached with the rhv.No intervention was taken.No harm or injury was reported.

• Brand Name: HYPERSOFT ADVANCED HYPERSOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5742299
• Report Number: 2032493-2016-00141
• Device Sequence Number: 10217
• Product Code: HCG
• UDI-Device Identifier: 00811425027714
• UDI-Public: (01)00811425027714(11)160420(17)210420(10)160420V2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2016

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: Physician
• Device Expiration Date: 04/20/2021
• Device Model Number: 8510-0154
• Device Lot Number: 160420V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Initial Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1