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

Model Number	7110-0728-1
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
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.The coil remains implanted; however, the pusher wire was returned for evaluation.The v-grip used for the procedure was not returned.The pusher wire had an open circuit.Destructive analysis on the black pet covering the heater coil was intact with no evidence of thermal damage, and both distal lead wires were broken from the solder joints.The severed monofilament was stretched and necked down, and rebounded back proximally into the pusher body coil, which is indicative of the monofilament having exceeded the filament thread maximum tensile specification.This likely lead to the break and resulting in force exerted to retract the coil system.Results of the product evaluation demonstrated a broken connector, which would have prevented detachment of the implant coil from the pusher due to the presence of an open circuit; however, it is unknown how or when the damage to the connector occurred.The v-grip used for the case was not returned; therefore, analysis of the v-grip and functional testing could not be performed.Based on the reported procedure details and the product evaluation, the complaints of coil non-detachment and coil break can be confirmed; however, the root cause of the non-detachment cannot be determined.
Event or Problem Description
It was reported that after positioning an embolization coil in an aneurysm, the coil would not detach.Multiple attempts were made to detach the coil, without success.During removal, the coil detached in the microcatheter.The coil was pushed back into the aneurysm without incident.There was no reported patient injury.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6492474
• Report Number: 2032493-2017-00089
• Device Sequence Number: 1268454
• Product Code: HCG
• UDI-Device Identifier: 00812636020341
• UDI-Public: (01)00812636020341(11)151102(17)201102(10)151102F1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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: 11/02/2020
• Device Model Number: 7110-0728-1
• Device Lot Number: 151102F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1