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

Model Number	45-780724-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during unspecified embolization procedure, the azur 18 xc coil unintentionally detached inside the microcatheter.The microcatheter along with the coil were removed from the patient.Another coil was used to complete the procedure.There was no report of harm or injury to the patient.
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 returned to the manufacturer and its evaluation was completed.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 implant loops deformed and separated from the pusher.Investigation of the pusher found the monofilament broken, which indicates the device experienced a tensile break.Investigation conclusion: the investigation of the returned coil system found the implant loops deformed and separated from the pusher.Inspection of the pusher found the monofilament with a tensile break shape at the tip, which is consistent with the device experiencing tensile 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 implant deformity, but this condition 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.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enerprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19008836
• Report Number: 2032493-2024-00253
• Device Sequence Number: 9402330
• Product Code: KRD
• UDI-Device Identifier: 00810170018329
• UDI-Public: (01)00810170018329(11)220629(17)270531(10)0000215319
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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: 45-780724-L
• Device Lot Number: 0000215319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• 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: 07/11/2023
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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