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

Model Number	45-780308-L
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization procedure, the coil was unable to detach using two different detachment controllers as they displayed a flashing red light.The coil was attempted to be removed, but it prematurely detached and remained implanted in a location that was not ideal, but acceptable.The procedure was completed successfully.There was no patient injury or intervention reported.This event had no impact on the patient.
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 implanted in the patient and will not be returned to the manufacturer for evaluation.A portion of the pusher was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If any portion of the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher returned without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.Further inspection found the pusher to be kinked at the distal section, and the lead wires to be separated from the core wire at the middle section of the pusher.The implant was not returned for evaluation as it remained in the patient as described in the reported event.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 unit also passed continuity and resistance testing using an in-house detachment controller, indicating the device was capable of thermal detachment.However, the detachment controller used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported detachment issue.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 CX 18D-LONGER
• Common Device Name: VASCULAR FOR PROMOTING 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: 19494832
• Report Number: 2032493-2024-00452
• Device Sequence Number: 12958258
• Product Code: KRD
• UDI-Device Identifier: 00816777024398
• UDI-Public: (01)00816777024398(11)240306(17)290228(10)0000543475
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: 45-780308-L
• Device Lot Number: 0000543475
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Unknown