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

Model Number	45-751324
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue 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 use of the device.Device has not yet been returned.
Event or Problem Description
It was reported that during a pelvic vein embolization procedure via the right cfv, an embolization coil implant became detached unexpectedly and stuck in the delivery catheter.The catheter and the coil were removed and the procedure continued.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant severely stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.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 evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
N/a.

• 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 Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17075052
• Report Number: 2032493-2023-00779
• Device Sequence Number: 6738909
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)220808(17)270731(10)0000243465
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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 Catalogue Number: 45-751324
• Device Lot Number: 0000243465
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• Patient Age: 32 YR
• Patient Sex: Female