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

Model Number	45-750812
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for analysis, but it has not been returned.The alleged device issue could not be verified.If it is received at a later date, an investigation will be performed and a supplemental report will be submitted.The instructions for use (ifu) identifies premature coil separation as a potential complication associated with use of the device.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.
Event or Problem Description
It was reported that while treating a watchman leak, a embolization coil implant was selected as the 7th coil for treatment.The coil would not fit in the coil pack so the physician pulled the coil back, but the coil disconnected from the pusher wire and the pusher wire unraveled in the catheter.The physician uses a balloon to trap the coil against the catheter and pull it out.The coil pack was sufficient and they were satisfied with the outcome.They did not need to place another coil and the procedure was completed.There was no injury.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant separated from the pusher and stretched and broken at the proximal section.The portion of the implant proximal to the break site was not returned for evaluation.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 implant damage, but the damage is consistent with the device experiencing forces exceeding the implant's yield and tensile strength.The catheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that while treating a watchman leak, a embolization coil implant was selected as the 7th coil for treatment.The coil would not fit in the coil pack so the physician pulled the coil back, but the coil disconnected from the pusher wire and the pusher wire unraveled in the catheter.The physician uses a balloon to trap the coil against the catheter and pull it out.The coil pack was sufficient and they were satisfied with the outcome.They did not need to place another coil and the procedure was completed.There was no injury.

• 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: 21542819
• Report Number: 2032493-2025-00205
• Device Sequence Number: 15387423
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: 00812636021058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/10/2025

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: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 0000752604
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown