MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE

Model Number	45-751019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
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.The reported issue 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: evar procedure with right groin access to coil the right internal iliac.Vessel measured 9mm, so used a 10mm cx 035 coil.Coil went out of catheter, tried to reposition, and then was unable to pull coil back into catheter or advance coil forward.Back end of pusher wire was able to come out, but part of the pusher wire / coil was still in the body within the catheter.It appears as if part of the pusher wire sheared off.A piece of the pusher wire was still in the catheter, so they were able to pull the entire catheter / remaining coil out of the body, as all parts of the coil and pusher were contained within the microcatheter; however, lost access to the internal iliac.The physician had to wire back into the internal iliac.Once we regained access, put in 10mm azur coils with no issue.The patient did not have any injury due to the reported event.The case was completed, and patient is fine.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the pusher returned without the implant attached, but no indications of activation using a detachment controller was found on the pusher heater coil.Further inspection found the pusher to be kinked with the outer sleeve damaged at the distal section.The implant was found to be stretched, separated from the pusher, and partially stuck within the returned catheter.The investigation found the pusher¿s monofilament with a tensile break shape at the tip, which is consistent with the device experiencing 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 pusher and implant damage, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The returned non microvention navicross support catheter was found crushed at 9cm from the distal tip, which may have caused or contributed to the reported complaint, and as a result, will inform the manufacturer of the catheter.
Event or Problem Description
Please see section h11 for device investigation results.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: AZUR
• 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: 20870458
• Report Number: 2032493-2024-00878
• Device Sequence Number: 8574496
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)240912(17)290831(10)0000703162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-751019
• Device Lot Number: 0000703162
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 035 GLIDEWIRE ADVANTAGE; 10CM 6FR PINNACLE INTRODUCER SHEATH; 10MM AZUR COILS; 135CM 035 NAVICROSS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown