MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL

Model Number	100254H2HS-V
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that resistance was encountered during advancement of the coil in the aneurysm.During removal, the coil detached in the microcatheter.Both segments were removed in their entirety from the patient.There was no reported intervention or patient injury.The patient was reported to be good.
Additional Manufacturer Narrative
The device was returned with the introducer and pusher for analysis.The monofilament was noted to be protruding from the distal tip of the heater coil by approx.6cm.The monofilament was confirmed to be properly secured at the attachment location.Both the pusher and introducer were noted to be in good condition and without damage.The distal tip of the monofilament was found to have a looped shape, which is indicative of a knot was performed at the distal location.The distal end appears to have a straight cut profile.Evidence of the proximal looping (proximal knot) of the monofilament was present on an area just inside the distal end of the pusher.Minor deformation was noted on the mono approx.1.5" from the distal tip of the monofilament for.5".The monofilament was noted to be wavy, with a partial coil-like imprint.Evidence of stretching in the monofilament could not be identified.The additional length in the monofilament cannot be accounted for based on the reported size of the implant.Based upon the investigation findings and available information, the reported complaint can be confirmed.The coil was detached from the pusher.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7672141
• Report Number: 2032493-2018-00131
• Device Sequence Number: 16836850
• Product Code: HCG
• UDI-Device Identifier: 00816777022912
• UDI-Public: (01)00816777022912(11)170325(17)220228(10)170325W4
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 02/28/2022
• Device Model Number: 100254H2HS-V
• Device Lot Number: 170325W4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1