MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100515H2HS-V
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
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 evaluation.A root cause cannot be determined.
Event or Problem Description
It was reported that during advancement of the coil in the microcatheter, the coil exit marker was noted to have "moved proximally." the fluoroscopy allegedly started with slight delay, but the coil was implanted in the aneurysm as intended.There was no reported patient injury or additional intervention.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10495332
• Report Number: 2032493-2020-00239
• Device Sequence Number: 2407430
• Product Code: HCG
• UDI-Device Identifier: 00810170012730
• UDI-Public: (01)00810170012730(11)200316(17)250228(10)2003165RR
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 100515H2HS-V
• Device Catalogue Number: 100515H2HS-V
• Device Lot Number: 2003165RR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• 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: 80 YR