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

Model Number	45-752039
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is reported available for return to the manufacturer for analysis.At this time the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
As reported, during treatment of a gastric varices embolization, the coil separated from wire detacher when trying to push in the vessel.No patient harm or injury reported.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher.-implant.Items not returned for evaluation: -catheter.The visual analysis of the returned device found the implant coil stretched at the proximal section but still attached to the pusher.The investigation of the returned coil system found the implant to be stretched at the proximal section.However, the implant was found to still be attached to the pusher.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported premature detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but this condition is consistent with the device experiencing forces exceeding the implant's yield strength.Based on our investigation findings and clarifying information received from the reporter, there was no coil detachment malfunction.The coil was stretched.Therefore, mvi no longer considers this event a reportable malfunction event.
Event or Problem Description
See h11.Change to section: h6- medical device problem code.

• 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 (Section G): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20696932
• Report Number: 2032493-2024-00835
• Device Sequence Number: 12379849
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)220103(17)261231(10)0000141170
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• 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): 12/17/2024

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 Expiration Date: 12/31/2024
• Device Model Number: 45-752039
• Device Lot Number: 0000141170
• Was Device Available for Evaluation?: Yes
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown