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

Model Number	7110-0931
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
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 not been returned to the manufacturer.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 venous sinus embolization for a dural arteriovenous fistula, the coil detached without use of the controller during removal from the coil mass.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.The patient was reported to be doing fine.
Additional Manufacturer Narrative
The implant was returned detached from the pusher; however, the pusher was not returned for analysis.The device was stretched from the proximal tie knot to the middle of the implant.The gel was found to be broken throughout the stretched location.The distal ball was measured at.0143", which is within specification.The monofilament was not visible inside the marker band.Based upon the investigation analysis and available information, the reported complaint was able to be confirmed.The strain relief and pusher monofilament were not available for evaluation, and the monofilament tail was not visible on the implant.The root cause cannot be determined; however, the damage to the implant is indicative of over specification tensile forces being placed on the device.

• 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: 8457874
• Report Number: 2032493-2019-00065
• Device Sequence Number: 354576
• Product Code: HCG
• UDI-Device Identifier: 00816777023759
• UDI-Public: (01)00816777023759(11)180315(17)230228(10)1803151W8
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/25/2019

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: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 7110-0931
• Device Lot Number: 1803151W8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR