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

Model Number	100206H2HS-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	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not been returned to the manufacturer.Therefore, the root cause of the complaint cannot be determined.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 an embolization coil implant became detached in the microcatheter.The implant was delivered without difficulty to the intended treatment site.There was no reported patient injury on intervention.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9242311
• Report Number: 2032493-2019-00250
• Device Sequence Number: 177936
• Product Code: HCG
• UDI-Device Identifier: 00811425020166
• UDI-Public: (01)00811425020166(11)190705(17)240630(10)1907055NR
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 06/30/2024
• Device Model Number: 100206H2HS-V
• Device Lot Number: 1907055NR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1