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

Model Number	45-780413-L
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
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 was stated to be available for analysis but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc.Will perform an investigation and will submit a supplemental mdr.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 during an embolization procedure, the coil unintentionally detached and stretched in the microcatheter.The coil and catheter were removed successfully from the patient.There was no report of harm or injury to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h10.Summary device evaluation: the investigation of the returned coil system found the pusher body coil damaged, and the implant still attached to the pusher with no signs of activation using a detachment controller.The unit passed continuity and resistance testing; furthermore, the implant was able to detach successfully during functional testing.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15009634
• Report Number: 2032493-2022-00268
• Device Sequence Number: 2414050
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)191212(17)241130(10)1912125ZA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/28/2022

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: 11/30/2024
• Device Model Number: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 1912125ZA
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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