MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; VASCULAR EMBOLIZATION DEVICE

Model Number	45-781639-L
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	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm embolization procedure, the coil unintentionally detached in the microcatheter when the physician attempted to pull the coil back into the microcatheter for re-positioning.The microcatheter with coil were successfully removed from the patient and another set of microcatheter and coil were used to complete the case successfully.Less than 250cc estimated blood loss.The patient was in stable condition.
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 analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation is completed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
Additional information: h10 (summary device evaluation).Summary device evaluation: the pusher and the implant were not returned for evaluation.The investigation of the returned microcatheter found the device in good condition.The implant coil was not found detached inside the microcatheter as described in the reported event.Since the coil system was not returned for evaluation, this investigation could not assess or test for the alleged detachment issue and therefore, this complaint is considered non-verifiable.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14161974
• Report Number: 2032493-2022-00157
• Device Sequence Number: 5932334
• Product Code: KRD
• UDI-Device Identifier: 00810170018381
• UDI-Public: (01)00810170018381(11)200320(17)250531(10)2006295ZA
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• 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): 03/28/2022

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: 05/31/2025
• Device Model Number: 45-781639-L
• Device Catalogue Number: 45-781639
• Device Lot Number: 2006295ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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