MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-652050
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	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a splenic aneurysm embolization case, the coil couldn't go through the glidecath.When the physician pulled the coil out of the catheter, the coil detached inside.A new catheter was used and the procedure was successful.No harm or injury was reported.
Additional Manufacturer Narrative
A search for non-conformances 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 stated to be available for evaluation but has not yet been returned.If the device is received the investigation will be performed and a supplemental report will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
The investigation of the returned coil system found the proximal connector kinked and the pusher damaged at the distal end.The implant was returned stretched, separated from the pusher, and stuck inside the microcatheter.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.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-35 DETACHABLE
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 15246160
• Report Number: 2032493-2022-00307
• Device Sequence Number: 5847379
• Product Code: KRD
• UDI-Device Identifier: 00810170016158
• UDI-Public: (01)00810170016158(11)210114(17)251231(10)2101145J8
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151358
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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 Expiration Date: 12/31/2025
• Device Model Number: 45-652050
• Device Catalogue Number: 45-652050
• Device Lot Number: 2101145J8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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
• Patient Sex: Unknown