MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-751632
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 discarded by the user facility and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.
Event or Problem Description
It was reported that during a procedure for a right pulmonary artery pseudoaneurysm, with access from the neck, the coil was deployed; however, physician was unsure if it would fit in the desired area.An attempt was made to back the coil out; however, the pusher wire broke, and the physician was able to snare the loose proximal portion of the coil and remove it in its entirety.There was no reported patient harm.

• Brand Name: AZUR CX 35 DETACHABLE
• 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 ; 7142478000
• MDR Report Key: 15306485
• Report Number: 2032493-2022-00316
• Device Sequence Number: 12352664
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)211018(17)260930(10)0000104455
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 08/06/2022

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 Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 0000104455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown