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

Model Number	7110-0520
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	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 has been returned to the manufacturer.The investigation is underway.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 treatment, an attempt was made to detach the coil with the controller; however, the coil did not detach.During removal, the coil detached in the microcatheter.Approximately 2cm of the coil was easily pushed into the aneurysm with the coil pusher and implanted successfully.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The proximal portion of the pusher was returned for analysis.The body coil was noted to be stretched and broken at the body coil hypotube transition.An electrical continuity test was unable to be tested, as the device was broken at the middle section.No analysis could be performed for the distal portion of the device, as it was not returned for analysis.Based upon the investigation analysis and available information, the reported complaint of unexpected detachment after non-detachment was unable to be verified.The distal portion of the pusher was not returned, preventing analysis of the condition of the monofilament, and the damage of the returned proximal portion of the pusher prevented testing of the electrical continuity.The root cause is unknown.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8331463
• Report Number: 2032493-2019-00022
• Device Sequence Number: 16559917
• Product Code: HCG
• UDI-Device Identifier: 00816777025265
• UDI-Public: (01)00816777025265(11)180508(17)230430(10)1805081W8
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2019

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 7110-0520
• Device Lot Number: 1805081W8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR