MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 CX DETACHABLE 4MM X 13CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780413-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
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 is being returned to the manufacturer for evaluation.The investigation is ongoing.
Event or Problem Description
It was reported that an embolization coil implant detached from the delivery pusher unexpectedly.The coil was in the proper position and so was left in place.There was no patient injury or intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system found the lead wires separated from the core wire on the entire length of the pusher, and the implant coils to be stretched with deformed loops; however, the implant coils were found to still be attached to the pusher upon receipt.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported premature detachment complaint.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.

• Brand Name: AZUR 18 CX DETACHABLE 4MM X 13CM
• Common Device Name: VASCULAR 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: 16123312
• Report Number: 2032493-2023-00011
• Device Sequence Number: 12900999
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)220112(17)261231(10)0000146276
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 0000146276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male