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

Model Number	100410H2HS-V
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	12/18/2018
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 been returned to the manufacturer.The investigation is underway.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 treatment for an unruptured aneurysm, the coil detached inside the microcatheter.The coil was removed in its entirety along with the microcatheter.There was no reported patient injury or intervention.The patient was reported to be normal.
Additional Manufacturer Narrative
The pusher, implant, introducer, and microcatheter were returned for analysis.The pusher was found to be undamaged.The strain relief was observed to be unburnt and in good condition.The microcatheter contained a kink approximately 20cm from the distal portion.The implant was returned inside the microcatheter beyond the kinked location.No damage was observed to the implant inside the microcatheter.A guidewire was inserted into the microcatheter, but resistance was felt at the proximal of the implant, and advancement of the implant was not possible.The microcatheter was then cut and the implant was pulled from the device.Some damage occurred to the implant during the attempted removal.The implant was covered with blood contamination, and was found to have lost its shape.The monofilament was removed from the pusher and it contained a stretched tail profile, with a rebound of 0.085." based upon the investigation analysis and available information, the reported complaint is confirmed.The implant was returned detached from the pusher.The implant detached in the microcatheter as a result of a tensile break in the monofilament.The break is indicative of over-specification tensile forces being placed on the device.The root cause of the friction could not be determined.

• 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: 8533834
• Report Number: 2032493-2019-00099
• Device Sequence Number: 2191486
• Product Code: HCG
• UDI-Device Identifier: 00816777022967
• UDI-Public: (01)00816777022967(11)180913(17)230831(10)1809135PR
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080666
• 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): 03/22/2019

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 100410H2HS-V
• Device Catalogue Number: 100410H2HS-V
• Device Lot Number: 1809135PR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 70