MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT; EMBOLIZATION COIL

Model Number	100304HC-S-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device involved in this event has not been returned for evaluation.Following completion of the investigation, a follow-up medwatch will be submitted.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during the embolization treatment of an aneurysm, the coil did not detach.Upon withdrawal, the coil detached within the microcatheter.The system was removed without incident.No harm or injury was reported.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5841577
• Report Number: 2032493-2016-00180
• Device Sequence Number: 598388
• Product Code: HCG
• UDI-Device Identifier: 00811425027455
• UDI-Public: (01)00811425027455(11)160311(17)210311(10)160311V2
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/06/2016

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: 03/11/2021
• Device Model Number: 100304HC-S-V-A
• Device Lot Number: 160311V2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2016
• Initial Report FDA Received Date: 08/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1