MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780620-L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was report that, upon opening the package, the implant coil was found to be missing.There was no patient involvement.
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 stated to be available for return to the manufacturer, but it has not yet been returned.The alleged product issue could not be confirmed.If the device is returned at a later date, an investigation will be performed and a supplemental report will be submitted.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7146516118
• MDR Report Key: 18243702
• Report Number: 2032493-2023-01083
• Device Sequence Number: 17784871
• Product Code: KRD
• UDI-Device Identifier: 00810170018312
• UDI-Public: (01)00810170018312(11)230126(17)271231(10)0000315729
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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 Model Number: 45-780620-L
• Device Lot Number: 0000315729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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 Sex: Unknown