MAUDE Adverse Event Report: MICROVENTION INC. AZUR-18 DETACHABLE HYDRO; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480415-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a coil embolization procedure, the physician advanced the coil inside the microcatheter and attempted to form a second loop, but it was unsuccessful.When the coil was retracted to be readjusted, it prematurely detached.The coil, microcatheter, and glide catheter were all removed from the patient.There was no patient injury or intervention.The procedure was successfully completed.
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 for evaluation, but it has not yet been returned.The alleged issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr 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 pusher damaged/kinked at the distal section, and the implant separated from the pusher with no signs of activation using a detachment controller on the pusher's heater coil.The implant was returned stretched, damaged, and partially 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.The returned microcatheter was found to be kinked at 3cm and 4cm from the distal tip, which may have caused or contributed to the reported event.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• 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 ; 7142478000
• MDR Report Key: 16873740
• Report Number: 2032493-2023-00707
• Device Sequence Number: 14885659
• Product Code: HCG
• UDI-Device Identifier: 00810170017919
• UDI-Public: (01)00810170017919(11)220223(17)270131(10)0000161766
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 45-480415-L
• Device Catalogue Number: 45-480415
• Device Lot Number: 0000161766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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