MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 18 ADVANCED; EMBOLIZATION COIL

Model Number	8218-0619
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the approved device history record indicated the lot met all release criteria.The device will not be returned for evaluation; therefore, the product analysis could not be performed.Device was not returned for evaluation so root cause of the complaint cannot be determined.
Event or Problem Description
It was reported that during the treatment of a eca branch, the coil prematurely detached partially within the vessel and the microcatheter.The coil was pushed to the intended site using the delivery pusher successfully without incident.No patient injury reported.

• Brand Name: COSMOS 18 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6092753
• Report Number: 2032493-2016-00281
• Device Sequence Number: 19238883
• Product Code: HCG
• UDI-Device Identifier: 00811425028728
• UDI-Public: (01)00811425028728(11)151113(17)201113(10)151113V7
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/13/2020
• Device Model Number: 8218-0619
• Device Lot Number: 151113V7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/10/2016
• 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: 15 YR