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

Model Number	7118-0931
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis.The root cause cannot be determined.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 a left internal carotid aneurysm was being treated.When the tech was backflushing the coil, a 60 degree bend was made on the pusher wire distal to the detachment joint/detachment segment.The bend was straightened and a v-grip detachment controller was tested on the detachment area.The v-grip exhibited a green light.After placement of the coil, the implant would not detach.After 2 attempts, it was decided to remove the coil.The coil would not advance nor be removed, and the coil broke in the carotid.A 4mm snare was deployed to removed the coil.The patient is reported to be fine.

• Brand Name: HYDROFRAME 18 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9177432
• Report Number: 2032493-2019-00235
• Device Sequence Number: 2830637
• Product Code: KRD
• UDI-Device Identifier: 00816777023957
• UDI-Public: (01)00816777023957(11)171108(17)221031(10)1711081W6
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 7118-0931
• Device Lot Number: 1711081W6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/10/2019
• 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