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

Model Number	45-480410-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was reported available for return for analysis, but has not yet been received and procedure images not provided.Therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a hepatic artery embolization procedure, the embolization coil prematurely detached with half of the coil outside the catheter.The physician attempted to push the coil in intended site with use of guidewire and coil pusher with no success.The coil was retrieved by pushing the 2.5fr microcatheter over about 80% and then pulled out through the mother catheter with aspiration (with everything crossed).There was no harm or injury to the patient.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h6, h10 (device evaluation).Investigation findings items returned for evaluation: pusher.Implant.Introducer.Items not returned for evaluation: microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher, and the pusher exhibited kinks at the distal section.The implant was returned stretched with the overcoil damaged at the proximal end and separated from the pusher.The investigation of the pusher found the monofilament broken, which indicates that the device experienced a tensile break.Investigation conclusion: the investigation of the returned coil system found the pusher kinked at the distal section, and the implant stretched with the overcoil damaged at the proximal end and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.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, 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: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 20027189
• Report Number: 2032493-2024-00616
• Device Sequence Number: 7476501
• Product Code: HCG
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)240112(17)281231(10)0000495116
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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 Model Number: 45-480410-L
• Device Lot Number: 0000495116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.7FR PROGREAT MICROCATHETER (TERUMO, INC.)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown