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

Model Number	45-751324
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 was not yet returned to the manufacturer; therefore, the product evaluaton could not be performed.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 during treatment of a pavm embolization, the coil was advanced to the treatment site with encountered resistance.The coil became stuck within the microcatheter and was not moving.The delivery pusher was withdrawn from the catheter with the implant remaining in the catheter.The catheter was withdrawn with the coil partially extending at the catheter tip.The case was completed with another coil.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device returned for evaluation.The microcatheter and pusher used in the procedure were not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The investigation of the returned coil system found the implant severely stretched at the proximal end with the uv glue bonds in spec.Due to the missing pusher, the investigation is unable to determine if the implant was thermally detached from the pusher or separated from the pusher; however, the damage found on the implant is consistent with the device experiencing excessive retraction forces over specification during withdrawal from the catheter used in the procedure.

• Brand Name: AZUR 35 CX 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: 12332513
• Report Number: 2032493-2021-00331
• Device Sequence Number: 14566556
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)200811(17)250731(10)2008115J2
• 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
• Report Date (Section B): 07/19/2021

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: 07/31/2025
• Device Model Number: 45-751324
• Device Catalogue Number: 45-751324
• Device Lot Number: 2008115J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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