MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	7110-0258-3D-A2
Medical Device Problem Codes	Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
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 was returned for evaluation.The implant coil was detached from the delivery pusher.The attachment tether was fully retracted into the marker band.The implant coil was stretched from the implant tie knot throughout the length of the coil.The tie knot was still present and the implant coil was complete, including the distal ball/uv glue, marker band, stretch resistance member, and the implant gel.The distal end of the pusher appeared to be within specifications.The proximal end of the pusher was cut at the hypotube distal of the gold connector.Based on the provided information, the reported difficulty during coil placement was unconfirmed, as the conditions of use in the patient cannot be recreated during bench testing; however, the investigation findings are comparable in nature as to cases in which the applied force during the retraction of the coil overcame the tensile strength of the device/materials.
Event or Problem Description
It was reported that during placement of the 5th embolization coil to treat a fistula in the cavernous portion of the internal carotid artery, the coil was unable to fit properly, despite multiple attempts to reposition it.During an attempt to remove the coil, the coil stretched, but did not detach.The entire coil was retrieved with a snare device.It was determined that the fistula was 95% treated, and the procedure was completed.There was no reported patient injury.The current patient's status is reported to be good.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6648673
• Report Number: 2032493-2017-00143
• Device Sequence Number: 10994508
• Product Code: HCG
• UDI-Device Identifier: 00816777025449
• UDI-Public: (01)00816777025449(11)170209(17)220131(10)170209W9
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• 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
• Report Date (Section B): 05/17/2017

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: 01/31/2022
• Device Model Number: 7110-0258-3D-A2
• Device Lot Number: 170209W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/16/2017
• 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: 31 YR