MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	45-681434-L
Medical Device Problem Codes	Migration (4003); Separation Problem (4043); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 complaint 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.The instructions for use (ifu) identifies difficult or premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
As reported, faulty release system.Removal of the coil by lasso.No consequences for patient.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher.-implant.Items not returned for evaluation: -introducer.-v-grip.The visual analysis of the returned device found the implant still attached to the pusher, but damaged and deformed, and the pusher exhibited kinks and lead wire separation.The device was tested with the 4-way continuity test using an in-house v-grip controller and all tries gave out green lights that turned to red lights.The pusher resistance was measured and gave 39.8 (spec=38-52), which is within specification and proximal resistance of ol (spec=overload) which is within the specification.Tested the unit for detachment using an in-house v-grip controller, but the implant did not detach after three attempts.
Event or Problem Description
Additional information provided indicated: the coil detachment failed during the procedure (splenic aneurysm).The clinician attempted to remove the device, but the coil was then released into the aorta, requiring it to be retrieved using a lasso.No consequence for the patient.

• Brand Name: AZUR-18 DETACH PLATINUM
• 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: 20447494
• Report Number: 2032493-2024-00757
• Device Sequence Number: 17919843
• Product Code: KRD
• UDI-Device Identifier: 00810170017803
• UDI-Public: (01)00810170017803(11)200227(17)250131(10)2002275K5
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120630
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 45-681434-L
• Device Lot Number: 2002275K5
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown