MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; PERIPHERAL

Model Number	45-781238-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's associated with the reported 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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention will issue a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment the coil prematurely detached within the microcatheter.The coil was removed together with the microcatheter.No patient harm or consequence was reported.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher; -implant; -introducer; -microcatheter.Items not returned for evaluation: -dispenser hoop; -shrink lock; -v-grip.The visual analysis of the returned items found the pusher returned partially advanced through the introducer with no implant attached, and the introducer distal tip damaged.The implant was found to be stuck in the returned microcatheter hub.The investigation of the pusher found the monofilament broken, which indicates the device experienced a tensile break.Inspection of the returned microcatheter did not reveal any signs of kinking or damage that could have caused or contributed to the reported complaint.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: PERIPHERAL
• 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: 16803082
• Report Number: 2032493-2023-00684
• Device Sequence Number: 1931756
• Product Code: KRD
• UDI-Device Identifier: 00810170018367
• UDI-Public: (01)00810170018367(11)211125(17)261031(10)0000129460
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 45-781238-L
• Device Catalogue Number: 45-781238
• Device Lot Number: 0000129460
• Was Device Available for Evaluation?: No
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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: Other
• Patient Sex: Unknown