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

Model Number	45-452030
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment and difficult or delayed coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a peripheral coil embolization procedure, the embolization coil did not detach and during removal, the embolization coil detached in the catheter.The coil was removed from the patient without incident.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The reported complaint is confirmed.The investigation of the returned coil system found that the implant did experience a tensile break based on the shape and profile of the monofilament.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 forces over specification.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11325948
• Report Number: 2032493-2021-00047
• Device Sequence Number: 10944866
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)191112(17)241031(10)1911125JG
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/10/2021

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: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 1911125JG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/13/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1