MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; PERIPHERAL

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	02/03/2023
Type of Reportable Event	Serious Injury
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned. if the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported during an embolization treatment, the coil would not detach.A second detachment controller was opened same issue, initially received green light but then immediately turned red, troubleshooting was implemented.The physician attempted to manually disconnect the coil and failed, and the coil spontaneously detached.The failed coil was removed with a snare.An attempt was made to re-implant the coil by utilizing guidewire to push coil through the catheter.No patient harm or injury was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant to be separated from the pusher with deformed loops.The pusher's heater coil showed signs of activation using a detachment controller.The investigation found the pusher¿s monofilament profiled a mushroom shape at the proximal end and a tensile break at the distal end, indicating that the implant experienced a sticky detachment.This condition is consistent with a partial thermal activation resulting in the implant to not separate until the device experienced force that exceeded the strength of the monofilament causing the implant to separate from the pusher, likely during device removal as described in the reported event.The unit did not pass continuity testing.Inspection of the pusher found the green lead wire damaged at the distal solder joint, which is consistent with implant coil not being able to be consistently activated by the controller during the procedure.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: PERIPHERAL
• 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: 16425368
• Report Number: 2032493-2023-00579
• Device Sequence Number: 20283173
• Product Code: HCG
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)210910(17)260831(10)0000081955
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 45-751324
• Device Catalogue Number: 45-751324
• Device Lot Number: 0000081955
• Was Device Available for Evaluation?: No
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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