MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-751632
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
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; however, its evaluation is not complete.A supplemental report will be submitted when the investigation is completed.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the case was for embolization of a left hypogastric artery using left femoral access.When the 4th coil was advanced it unintentionally detached in the microcatheter.Physician attempted to flush and push out the coil but was unsuccessful.The coil was removed along with the microcatheter and replaced with another coil to successfully complete the case.The patient was fine.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Additional information: h3, h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the implant to be severely stretched at the proximal section with the gel exposed, damaged, deformed and separated from the pusher.The pusher's heater coil showed no signs of activation using a detachment controller.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, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16376005
• Report Number: 2032493-2023-00570
• Device Sequence Number: 6142602
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)211125(17)261031(10)0000129474
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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 Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 0000129474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG