MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 20MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-482030-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
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 returned to the manufacturer for evaluation.The investigation is currently underway.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 the embolization coil unexpectedly detached inside the microcatheter without use of the detachment controller.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The device was returned with guidewire and embolization coil within the microcatheter.The pusher inspection identified a tensile break of the monofilament rather than a separation of the implant due to an activation of a detachment controller.The inspection of the returned microcatheter found damage consistent with the product use that might have resulted in increased resistance during deployment; resistance during retraction would have led to a separation of the implant if the retraction force exceeded the tensile strength of the monofilament.The physical evaluation of the microcatheter could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 20MM X 30CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10469094
• Report Number: 2032493-2020-00237
• Device Sequence Number: 3001360
• Product Code: HCG
• UDI-Device Identifier: 00810170018084
• UDI-Public: (01)00810170018084(11)170620(17)220531(10)17062053Z
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 05/31/2022
• Device Model Number: 45-482030-L
• Device Catalogue Number: 45-482030
• Device Lot Number: 17062053Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention