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	11/22/2022
Type of Reportable Event	Malfunction
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 but has not yet been returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.If and when the device is received, an investigation will be performed and a supplemental report will be submitted.The instructions for use states that premature coil separation is a potential complication associated with use of the device.
Event or Problem Description
It was reported that an embolization coil implant detached prematurely during repositioning.The catheter was removed with the coil inside of it.There was no intervention or injury.
Additional Manufacturer Narrative
The reported complaint is unconfirmed.Inspection of the implant found the proximal section to be stretched.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); however, the implant coils found to be attached to the pusher upon receipt.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.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.
Additional Manufacturer Narrative
Additional information: d4, h4 lot number received via email.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16131821
• Report Number: 2032493-2023-00010
• Device Sequence Number: 7673288
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)210223(17)260131(10)2102235K2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 2102235K2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 02/10/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/02/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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
• Patient Sex: Unknown