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

Model Number	45-751019
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.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
It was reported that the physician was attempting to seal a residual leak following a watchman procedure in the left atrial appendage.The coil was advanced through a 6f coronary guide catheter; however, the lumen of the catheter was believed to be too large.The coil subsequently detached prematurely within the 6f guide catheter and did not exit the tip of the catheter, becoming lodged within the system.It was reported that the physician was able to successfully snare and retrieve the coil without any harm to the patient.An amplatzer plug was then used to treat the leak behind the watchman device.
Event or Problem Description
It was reported that the physician was attempting to seal a residual leak following a watchman procedure in the left atrial appendage.The coil was advanced through a 6f coronary guide catheter; however, the lumen of the catheter was believed to be too large.The coil subsequently detached prematurely within the 6f guide catheter and did not exit the tip of the catheter, becoming lodged within the system.It was reported that the physician was able to successfully snare and retrieve the coil without any harm to the patient.An amplatzer plug was then used to treat the leak behind the watchman device.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched and bunched up at the proximal section, separated from the pusher, and partially stuck within the catheter.The investigation found the implant's monofilament at the tie knot showed 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 stretched implant, but stretching is consistent with the device experiencing forces exceeding the implant's yield strength.The returned catheter was not found damaged and would not have caused or contributed to the reported complaint.

• Brand Name: AZUR CX 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: 24787196
• Report Number: 2032493-2026-00226
• Device Sequence Number: 9904784
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)250822(17)300731(10)0001258578
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 0001258578
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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: 6F CORONARY GUIDE; 6F CORONARY GUIDE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown