MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	182065CS-V
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	03/02/2022
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 returned to the manufacturer for evaluation.The investigation is currently underway.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 an embolization implant coil detached unexpectedly.The implant was removed without the need for intervention.There was no reported injury to the patient.The patient's condition was reported to be "good.".
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant intact with no notable damage and to be attached to the pusher.No burn marks were found on the pusher's heater coil.The investigation found the pusher's body coil damaged 2" from the distal heater coil and lead wire separation starting 24" from the proximal connector.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 investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13935101
• Report Number: 2032493-2022-00113
• Device Sequence Number: 4132162
• Product Code: HCG
• UDI-Device Identifier: 00810170014185
• UDI-Public: (01)00810170014185(11)200311(17)250228(10)2003115Q1
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K090891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 182065CS-V
• Device Catalogue Number: 182065CS-V
• Device Lot Number: 2003115Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2020
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 74 KG