MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-451020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
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 has not been returned to the manufacturer for evaluation.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 after the implant coil partly emerged from the catheter, the coil stopped advancing.During the attempt to remove the device, the coil detached from the pusher wire.A.035 guide wire was used to push the implant coil into the treatment site.There was no reported patient injury or additional intervention.The patient's current condition is reported to be "stable/unremarkable.".
Additional Manufacturer Narrative
The investigation of the returned coil system confirmed the implant was detached from the pusher.The implant was not returned for evaluation.The pusher was received damaged at the distal end with no indication of activation using a detachment controller on the heater coil.The pusher's monofilament profiles a tensile break shape indicating excessive force was applied to the monofilament during retraction.Due to the separation of the implant, replication testing could not be performed to determine the cause of the advancement issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing excessive forces.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10423558
• Report Number: 2032493-2020-00211
• Device Sequence Number: 2942995
• Product Code: KRD
• UDI-Device Identifier: 00810170014970
• UDI-Public: (01)00810170014970(11)191217(17)241130(10)1912175KG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/05/2020

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: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 45-451020
• Device Catalogue Number: 45-451020
• Device Lot Number: 1912175KG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 07/19/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1