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

Model Number	45-750511
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	05/27/2021
Type of Reportable Event	Malfunction
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 implanted in the patient and not available for return to the manufacturer for analysis.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the vascular embolization coil implant was used in a splenic embolization procedure when the coil unexpectedly detached without use of a detachment controller.When the pusher wire was removed, a small filament came out of the catheter.The pusher wire was removed and a wire was used to push it out but it would not advance through the catheter.Reportedly, the patient is stable and unaffected and the embolization procedure completed successfully.
Additional Manufacturer Narrative
Additional information received confirming the entire coil was removed from the patient.When the coil did not come out of the plastic housing, x-ray was used to see where it was getting stuck.The coil and microcatheter were removed together and the case was completed by using additional azur coils.Tried to push the coil out of the housing on the back table, but it would not come out.The defective coil was discarded.

• Brand Name: AZUR 35 CX DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12072077
• Report Number: 2032493-2021-00259
• Device Sequence Number: 3926576
• Product Code: KRD
• UDI-Device Identifier: 00812636021027
• UDI-Public: (01)00812636021027(11)191118(17)241031(10)1911185J2
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 10/31/2024
• Device Model Number: 45-750511
• Device Catalogue Number: 45-750511
• Device Lot Number: 1911185J2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 94