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

Model Number	100154HFRM-V
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
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 balloon-assisted coil embolization of a small, wide neck middle cerebral artery aneurysm, the coil would not stay in the aneurysm during positioning.During removal, the coil stretched at the hub of the microcatheter and then detached from the pusher wire.There was no reported patient injury or intervention.The patient was reported to have been discharged a few days post-procedure.
Additional Manufacturer Narrative
Upon receipt, the device was noted to be tightly wound into a coil.The unit was untangled and the pusher was found to be kinked in multiple locations throughout the body.Additionally, the pusher was found to be bent and broken at the transition location.The implant coil was still attached, but was broken just distal to the proximal tie knot location.The primary wind filar and monofilament were broken.The introducer sheath was also found to have minor damage at the tip.Based upon the investigation findings and available information, the reported complaint is confirmed, as the implant was found to be broken upon return from the field.The distal end of the implant was missing and was not returned.The root cause cannot be determined from the information provided.The distal end of the implant and microcatheter are considered critical components for the root cause analysis.

• Brand Name: HYDROSOFT 3D
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8441767
• Report Number: 2032493-2019-00061
• Device Sequence Number: 19481512
• Product Code: HCG
• UDI-Device Identifier: 00816777026477
• UDI-Public: (01)00816777026477(11)180516(17)230430(10)1805161W9
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K161367
• 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): 02/19/2019

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: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 100154HFRM-V
• Device Catalogue Number: 100154HFRM-V
• Device Lot Number: 1805161W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 55