MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480815-L
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	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physician phone number: (b)(6).A search for non-conformances 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 returned to the manufacturer and the invstigation is still ongoing.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a splenic artery aneurysm embolization, access achieved into splenic aneurysm and successfully delivered multiple embolization coils.An azur 45-480815 was introduced.The coil advanced without issue to distal portion of microcatheter.About 1cm of coil was advanced out of microcatheter before microcatheter kicked back.Coil retracted and re-advanced multiple times to allow coil to soften.The coil became stuck and would not advance further.During attempt to withdraw the coil, it detached in microcatheter.Microcatheter and coil were removed together successfully.Procedure was completed successfully with additional coils.No patient harm or intervention was reported.
Additional Manufacturer Narrative
The investigation found that the monofilament profile did not have a mushroom shape, indicating that a tensile detachment had occurred during the procedure.There was no fault to the circuitry of the pusher, as it had passed resistance and continuity testing, and no short condition was present.The physical evaluation of the device could not identify the conditions or circumstances that led to the damages to the pusher, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11926002
• Report Number: 2032493-2021-00215
• Device Sequence Number: 14248495
• Product Code: HCG
• UDI-Device Identifier: 00810170017971
• UDI-Public: (01)00810170017971(11)200306(17)250228(10)2003065KB
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 02/28/2025
• Device Model Number: 45-480815-L
• Device Catalogue Number: 45-480815
• Device Lot Number: 2003065KB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR