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

Model Number	100310H2HS-V-A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation.An analysis of the actual sample could not be performed and the root cause of this complaint could not be determined.(b)(4).
Event or Problem Description
It was reported from (b)(6) that the coil was unable to detach with a v-grip controller.The physician decided to withdrawal the coil; however, the coil detached during withdrawal.No patient injury was reported with this event.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5958851
• Report Number: 2032493-2016-00219
• Device Sequence Number: 889526
• Product Code: HCG
• UDI-Device Identifier: 00811425026427
• UDI-Public: (01)00811425026427(11)160220(17)210220(10)160220V9
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/20/2021
• Device Model Number: 100310H2HS-V-A
• Device Lot Number: 160220V9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• 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: 62 YR
• Patient Weight: 53