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

Model Number	45-751324
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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 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
As reported: the hospital staff were given the device, and it was noted that the coil detached in the base catheter and was successfully removed from the patient.It was marked as a malfunction only and there was no patient impact, injury or intervention.Although requested, the reporter had no additional information.
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.Investigation findings: items returned for evaluation: pusher, implant.Items not returned for evaluation: introducer, shrink lock, dispenser hoop, catheter.The visual analysis of the returned device found that the implant was not attached to the pusher, and the proximal connector was kinked.The implant was returned stretched at the proximal section and separated from the pusher.The investigation of the pusher found that the monofilament was broken, which indicates that the device experienced a tensile break.Investigation conclusion: the investigation of the returned coil system found the proximal connector kinked, and the implant stretched at the proximal section and separated from the pusher; however, no indications of thermal activation using a detachment controller was found on the pusher heater coil.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 stretch and separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the proximal connector kink, but the kink is consistent with the device experiencing forces exceeding the proximal connector's yield strength.The catheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
No additional information was received.

• 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: 20372125
• Report Number: 2032493-2024-00739
• Device Sequence Number: 17116127
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)230113(17)271231(10)0000309336
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 45-751324
• Device Lot Number: 0000309336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown