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

Model Number	45-750617
Medical Device Problem Codes	Unraveled Material (1664); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: the coil could be inserted and placed in the vessel via the catheter without any problems; detachment with the controller also went as usual.The wire could be withdrawn without resistance and without moving the coil.During the visual inspection before inserting the next coil, an approximately 12cm long piece of the coil (pulled into the length) was found in the end piece of the inserted catheter.This defective part of the coil protruded into the brachiocephalic trunk and could be retrieved from the patient together with the remaining coil.The same size was taken from the consignment store again and fitted without any problems.No harm to patient.
Additional Manufacturer Narrative
Items returned for evaluation: implant.Items not returned for evaluation: pusher, introducer, and catheter.The implant was returned stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found the implant's monofilament to have a mushroom profile at the proximal end with tensile break at the distal end, indicating that the device experienced delayed detachment.The investigation of the returned coil system found the implant to be stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found the implant's monofilament profiled a mushroom shape at the proximal end and a tensile break at the distal end, indicating that the implant experienced a partial/delayed detachment.This condition is consistent with a partial thermal activation resulting in the implant to not separate until the device experienced force that exceeded the strength of the monofilament causing the implant to separate from the pusher, likely during device withdrawal as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but stretching is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
As reported: the coil could be inserted and placed in the vessel via the catheter without any problems; detachment with the controller also went as usual.The wire could be withdrawn without resistance and without moving the coil.During the visual inspection before inserting the next coil, an approximately 12cm long piece of the coil (pulled into the length) was found in the end piece of the inserted catheter.This defective part of the coil protruded into the brachiocephalic trunk and could be retrieved from the patient together with the remaining coil.The same size was taken from the consignment store again and fitted without any problems.No harm to patient.
Event or Problem Description
As reported: the coil could be inserted and placed in the vessel via the catheter without any problems; detachment with the controller also went as usual.The wire could be withdrawn without resistance and without moving the coil.During the visual inspection before inserting the next coil, an approximately 12cm long piece of the coil (pulled into the length) was found in the end piece of the inserted catheter.This defective part of the coil protruded into the brachiocephalic trunk and could be retrieved from the patient together with the remaining coil.The same size was taken from the consignment store again and fitted without any problems.No harm to patient.
Additional Manufacturer Narrative
Corrected medical device problem code in section h to "unraveled material.".

• 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: 20635317
• Report Number: 2032493-2024-00809
• Device Sequence Number: 7404263
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)240308(17)290228(10)0000544804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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: 45-750617
• Device Lot Number: 0000544804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/14/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/10/2025; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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