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

Model Number	100520H2HS-V-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
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 implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that upon removing the delivery pusher from the dispenser hoop, the delivery pusher was observed to be bent.The device passed the pre-test.During positioning, the implant coil detached from the delivery pusher.The coil was removed successfully using an endovascular snare.The patient was reported to be "good." there was no reported patient injury or sequela.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11579782
• Report Number: 2032493-2021-00096
• Device Sequence Number: 11668044
• Product Code: HCG
• UDI-Device Identifier: 00816777023018
• UDI-Public: (01)00816777023018(11)200518(17)250430(10)2005185WR
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 100520H2HS-V-A2
• Device Catalogue Number: 100520H2HS-V
• Device Lot Number: 2005185WR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention