MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7110-0715-A2
Medical Device Problem Codes	Unraveled Material (1664); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's associated with the reported 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 implanted in the patient and was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the alleged product issue cannot be confirmed.The instructions for use identifies delayed or difficult coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a ruptured aneurysm of the posterior communicating artery, an embolization coil implant could not be retracted into the microcatheter.Attempts to detach the implant with a detachment controller did not work.All access devices were withdrawn and the implant and portion of the pusher wire were left in the vasculature from the pcom to the femoral access point.The patient's status is currently stable.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11750666
• Report Number: 2032493-2021-00157
• Device Sequence Number: 4244348
• Product Code: HCG
• UDI-Device Identifier: 00816777023711
• UDI-Public: (01)00816777023711(11)190613(17)240531(10)1906131WF
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 05/31/2024
• Device Model Number: 7110-0715-A2
• Device Lot Number: 1906131WF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1