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

Model Number	7210-0254-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 pusher was the only component received for evaluation.The investigation of the returned pusher found the distal end severely stretched and broken with the distal heater coil missing.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The instructions for use (ifu) identifies premature detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization procedure of an aneurysm, the pusher unintentionally detached in the microcatheter aft deployment.The "enitire" coil was removed coil from the patient.Another coil was used to successfully complete the case.The patient is fine.

• Brand Name: HYDROSOFT 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12858515
• Report Number: 2032493-2021-00466
• Device Sequence Number: 4608622
• Product Code: HCG
• UDI-Device Identifier: 00816777023100
• UDI-Public: (01)00816777023100(11)200915(17)250831(10)2009151WR
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 08/31/2025
• Device Model Number: 7210-0254-A2
• Device Lot Number: 2009151WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female