MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-751324
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pelvic congestion procedure, the third coil did not traverse through the catheter as smooth as the previous two.The catheter did have a steep angulation to negotiate from right to patient left.The coil was inserted and removed several times as the surgeon attempted to land the coil in desired location.While positioning the coil, the tech was placing the controller on the back in preparation of deployment.During repositioning and/or when the tech was following with the controller, the coil separated without intentional deployment.The coil and catheter were removed and retrieved from within the catheter.No patient injury resulted.Procedure was completed with the placement of two additional coils with same microcatheter after previous coil removed.The procedure completed successfully and no reported injury to 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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or new information is received, mvi, inc., will issue a supplemental report.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12902371
• Report Number: 2032493-2021-00471
• Device Sequence Number: 14640350
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)210507(17)260430(10)2105075J2
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 11/03/2021

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 Expiration Date: 04/30/2026
• Device Model Number: 45-751324
• Device Catalogue Number: 45-751324
• Device Lot Number: 2105075J2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Sex: Female