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

Model Number	45-751324
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was originally reported that a non-reportable device malfunction occurred; however, additional clarifying information was received indicating that a reportable device malfunction occurred.Therefore, this report was filed to address the new clarifying information.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.Investigation conclusion: the physical evaluation of the returned device found the implant severely stretched and separated from the pusher.No signs of activation were found on the heater coil.The condition of the returned device is consistent with the implant encountering resistance, followed by retraction force that exceeded the strength of the coil winding (i.E.Stretching) and the strength of the attachment monofilament (i.E.Separation from the pusher).The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was originally reported that the coil stretched and did not detach; however, additional information received stated that after the operator flushed the coil and inserted it into the catheter, the coil was then attempted to be advanced through the catheter.The first loop of the coil moved out of the distal tip of the catheter, but the other remaining part of the coil was stuck inside the catheter.The operator tried to retract the coil, but the coil was already detached.The coil and catheter were both removed together from the patient.There was no intervention, and no patient injury was reported.The patient was not harmed.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR PROMOTING EMBOLIZATION DEVICE
• 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: 17322348
• Report Number: 2032493-2023-00850
• Device Sequence Number: 5510067
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)220103(17)261231(10)0000141538
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 45-751324
• Device Catalogue Number: 45-751324
• Device Lot Number: 0000141538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• 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: 06/22/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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