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

Model Number	100520HCSR-R-V-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided, the root cause of this complaint cannot be determined.The device was reported unavailable for evaluation.(b)(4).
Event or Problem Description
It was reported from (b)(6) that upon detaching the coil, the physician could not retrieve the coil.The coil does not completely detach from the pusher.The physician attached implant to the vessel wall using a stent.No patient injury was reported with this event.

• Brand Name: MICROPLEX HELICAL REGULAR
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5958917
• Report Number: 2032493-2016-00227
• Device Sequence Number: 839794
• Product Code: HCG
• UDI-Device Identifier: 00811425025048
• UDI-Public: (01)00811425025048(11)160228(17)210228(10)160228V9
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/23/2016

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: 02/28/2021
• Device Model Number: 100520HCSR-R-V-A
• Device Lot Number: 160228V9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 09/17/2016
• 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: 56 YR
• Patient Weight: 71