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

Model Number	45-480620-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization treatment, the coil prematurely detached within the microcatheter.The microcatheter and coil were withdrawn together successfully.No patient harm or injury was reported.
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 has not yet been returned.The alleged product issue/event as described 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.
Event or Problem Description
It was reported that during an embolization treatment, the coil prematurely detached within the microcatheter.The microcatheter and coil were withdrawn together successfully.No patient harm or injury was reported.
Additional Manufacturer Narrative
Investigation findings items returned for evaluation: -pusher -implant -introducer items not returned for evaluation: -dispenser hoop -shrink lock -microcatheter -v-grip the visual analysis of the returned items found the pusher returned with no implant attached, and the pusher heater coil showed signs of activation using a detachment controller.The implant was found to be separated from the pusher, exhibiting damage and stretching at the proximal end, and was stuck inside the introducer.The investigation of the pusher found the monofilament broken, indicating that the device experienced a tensile break.Investigation conclusions investigation conclusion the investigation of the returned coil system found the implant damaged and stretched at the proximal end and separated from the pusher.The pusher¿s heater coil showed signs of activation using a detachment controller.However, the investigation found the pusher¿s monofilament with a tensile break shape at the tip, which is consistent with the device experiencing 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 microcatheter used in the procedure was not returned for evaluation so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 17734631
• Report Number: 2032493-2023-00933
• Device Sequence Number: 6543366
• Product Code: HCG
• UDI-Device Identifier: 00810170017957
• UDI-Public: (01)00810170017957(11)211004(17)260930(10)0000095952
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2023

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 Expiration Date: 09/30/2026
• Device Model Number: 45-480620-L
• Device Lot Number: 0000095952
• Was Device Available for Evaluation?: Yes
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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