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

Model Number	45-450620
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
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 was returned to the manufacturer and evaluation is not complete.A supplemental report will be issued once investigation is complete.
Event or Problem Description
It was reported that during the embolization treatment the coil was advanced in the catheter and it was observed that the implant coil was not visible.The coil was not located at the distal end of the delivery system or within the catheter.The coil was not found at the prep area prior to insertion.No patient harm or injury was reported.
Additional Manufacturer Narrative
The pusher and introducer were the only components returned for evaluation.The investigation of the returned coil system found the implant to be separated from the pusher with no signs of activation on the heater coil.Dry blood contamination was found on the pusher's heater coil and strain relief.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage or when this occurred, 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
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12628428
• Report Number: 2032493-2021-00405
• Device Sequence Number: 4522653
• Product Code: KRD
• UDI-Device Identifier: 00810170014932
• UDI-Public: (01)00810170014932(11)200128(17)241231(10)2001285JG
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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: 12/31/2024
• Device Model Number: 45-450620
• Device Catalogue Number: 45-450620
• Device Lot Number: 2001285JG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown