MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 10 ADVANCED; EMBOLIZATION COIL

Model Number	7310-1030
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned to the manufacturer for analysis; therefore, a product evaluation could not be performed.The root cause is unknown.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization procedure, part of the embolization coil detached in the artery.An attempt was made to remove the coil; however, the attempt was unsuccessful and the patient was taken to surgery.No further information was provided.
Additional Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 06/08/2018.

• Brand Name: HYDROFILL 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7666688
• Report Number: 2032493-2018-00128
• Device Sequence Number: 13715644
• Product Code: HCG
• UDI-Device Identifier: 00816777023452
• UDI-Public: (01)00816777023452(11)170913(17)220831(10)1709131W1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 7310-1030
• Device Lot Number: 1709131W1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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: 66 YR