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

Model Number	45-750812
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physcian was embolizing a gastric varice through a competitors balloon catheter.The physician deployed several coils with no incident.The physician then tried to reposition the event coil.Subsequently, the coil began to unravel and detached within the catheter.The balloon catheter and coil were then removed together.There was no effect to the patient.
Additional Manufacturer Narrative
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.The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue/event as described could not be confirmed.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 coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
No additional information received see d10, h6 and h10.
Additional Manufacturer Narrative
The visual analysis of the returned items found the implant coils stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found the implant's monofilament at the tie knot broken, indicating that the device experienced a tensile break.The investigation of the returned coil system found the implant stretched at the proximal section and separated from the pusher.This condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the aneurysm (i.E.Stuck on previously implanted coils or the tip of the microcatheter).The investigation found that the implant's monofilament at the tie knot showed a tensile break shape at the tip, which is consistent with the device experiencing excessive 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 stretched implant but stretching is consistent with the device experiencing retraction forces over specification.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.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 18619699
• Report Number: 2032493-2024-00092
• Device Sequence Number: 2405839
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)230425(17)280331(10)0000354782
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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): 03/27/2024

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: 45-750812
• Device Lot Number: 0000354782
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FOGARTY BALLOON CATHETER 6F PINNACLE SHEATH.
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 147 KG