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

Model Number	100308H2HS-V-A2
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis and the alleged product issue cannot be confirmed.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 stent-assisted coiling was performed for an acom aneurysm.During retraction of the coil into the microcatheter for repositioning, the coil stretched and then detached.Most of the coil was contained within the aneurysm sac and a small segment of stretched coil extended into the internal carotid artery.No additional intervention was performed.The aneurysm was successfully embolized and the procedure was completed.There was no reported patient injury.The patient is reported to be "fine" and without any neurological abnormalities.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10497820
• Report Number: 2032493-2020-00244
• Device Sequence Number: 2344406
• Product Code: HCG
• UDI-Device Identifier: 00816777022936
• UDI-Public: (01)00816777022936(11)200313(17)250228(10)2003135PR
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 02/28/2025
• Device Model Number: 100308H2HS-V-A2
• Device Catalogue Number: 100308H2HS-V
• Device Lot Number: 2003135PR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR