MAUDE Adverse Event Report: MICROVENTION INC. AZUR CX DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-780413-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an embolization coil implant was the fifth coil to be deployed in the patient.The coil did not detach so it was removed.Two additional coils were implanted after this coil.There was no injury or intervention.Once received, the investigation of the returned device showed that the device had pulled out a previously placed coil when it was removed from the patient.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher, -azur hydrocoil implant, -introducer, -dispenser hoop.Items not returned for evaluation: -shrink lock, -microcatheter, -v-grip, -azur cx implant.The visual analysis of the returned items found that the implant was not attached to the pusher and the pusher heater coil burnt.An implant was found stretched at the proximal section and entangled on the distal end of the pusher; an overcoil was observed on the implant, indicating that this implant is from an azur hydrocoil system.Therefore, the implant associated with the reported azur cx coil system was not returned.The device was tested with the 4-way continuity test using an in-house v-grip controller, and all tries gave out green lights.The pusher resistance was measured and gave 39.3 (spec=38-52) which is within specification, and proximal resistance of ol (spec=overload ) which is within specification.Furthermore, the investigation of the pusher found the monofilament with mushroom profile, which indicates that the device experienced thermal activation and the azur cx implant was successfully detached.The investigation of the returned coil system found the pusher heater coil burnt with no implant attached, indicating that the device did experience thermal activation from a detachment controller.Furthermore, the unit passed continuity and resistance testing and the pusher's monofilament profiled a mushroom shape, which is consistent with successful implant detachment.However, an implant was returned stretched at the proximal section and entangled on the distal end of the pusher, which would appear as if the implant did not detach under fluoroscopy.An overcoil was observed on the returned implant, indicating that the returned implant originated from an azur hydrocoil system that was used during the procedure as described in the reported event.This condition is consistent with the azur hydrocoil implant being pulled out of the target site by the reported azur cx pusher post-azur cx implant detachment.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: DEVICE, 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: 20243266
• Report Number: 2032493-2024-00694
• Device Sequence Number: 7235182
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: 00810170018299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 45-780413-L
• Device Catalogue Number: 45-780413
• Device Lot Number: 0000381053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• 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: 08/30/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 89 KG