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

Model Number	45-751019
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	11/24/2021
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 has not yet been returned to the manufacturer; therefore, a product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a fistula, an embolization coil implant detaced prematurely within the catheter.The coil was removed and another was used.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The implant was returned along with the snare, which was stuck in the microcatheter.The coil pusher was not returned.Without the return and evaluation of the pusher, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).No notable conditions were found on the returned microcatheter.The implant was returned damaged, which is consistent with using a snare device to retrieve it as indicated in the complaint.Since the investigation could not verify the mode of implant separation due to the absence of the pusher, the reported event is considered non-verifiable.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13058220
• Report Number: 2032493-2021-00505
• Device Sequence Number: 14425045
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)210528(17)260430(10)2105285J2
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 04/30/2026
• Device Model Number: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 2105285J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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