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

Model Number	45-780828-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's 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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.A portion of the device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported on (b)(6) 2024, the interventional radiologist was performing a mesenteric artery angiogram and embolization.While tracking out of the catheter, the coil became detached prematurely without using the detacher device.There was no harm to the patient, as the coil was in a satisfactory position in the artery.The anatomy was reported to be very tortuous.It is documented the "patient was end stage liver disease and has since deceased, unrelated to the product failure or procedure performed." this report captures only the device malfunction, premature separation, as the subsequent death was reported to be unrelated to the device.No other information was made available.
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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.Investigation findings items returned for evaluation: -pusher items not returned for evaluation: -implant -introducer -microcatheter the visual analysis of the returned device found that the implant was not attached to the pusher.The implant was not returned for evaluation.The investigation found that the pusher's monofilament was broken, indicating that the device experienced a tensile break.Investigation conclusion the investigation of the returned coil system found the implant to be separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The implant 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 microcatheter 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
No additional information or clarification was received.Please see h6 & h11.

• 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 (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20632411
• Report Number: 2032493-2024-00808
• Device Sequence Number: 12627148
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: (01)00810170018336(11)221116(17)271031(10)0000288330
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/09/2024

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 Model Number: 45-780828-L
• Device Lot Number: 0000288330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROGREAT 150CM 2.4 UNKNOWN DETAILS.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White