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

Model Number	7110-0308-3D-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2017
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 detached and within the microcatheter.Analysis of the monofilament found striations, which is indicative of tensile stretching.Results of the product evaluation confirmed the complaint.The force exerted during manipulation/retracting the coil system is consistent with the monofilament of the coil being subjected to force exceeding its tensile strength.
Event or Problem Description
It was reported that coil embolization treatment was performed on a ruptured aneurysm.After almost all of the second coil had been placed, the decision was made to exchange the coil.During retraction, the coil detached, leaving a segment of the coil outside the aneurysm.An attempt was made to retrieve the coil with a snare device; however, the snare broke.A second snare was used to retrieve both the coil and the broken snare.There was no reported patient injury.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6683042
• Report Number: 2032493-2017-00157
• Device Sequence Number: 1444748
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)170508(17)220430(10)1705081W9
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/02/2017

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: 04/30/2022
• Device Model Number: 7110-0308-3D-A2
• Device Lot Number: 1705081W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/30/2017
• 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: 34 YR
• Patient Weight: 64