MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480415-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	07/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was treating a 2.8mm a gastroduodenal artery (gda) aneurysm and was given an azur hydro coil instead of an azur cx by a new technician.The physician pushed the first loop out just fine and then the coil just came out straight.The physician paused for 15-30 seconds to let the coil soften and attempted to push the coil out of the microcatheter again.This time it pushed the microcatheter back and physician tried to track the catheter over the coil when a pop was felt, and the coil broke off of the pusher wire.The physician then pulled the microcatheter and coil out and was able to remove the coil from the microcatheter on the back table.Procedure was completed successfully using other azur cx coils, and the patient was stable.
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
Additional information: d9 (date device returned), h6, h10 (summary device evaluation).Summary deivce evaluation: the investigation of the returned coil system found the implant stretched, damaged, and separated from the pusher.The pusher was not returned for evaluation; furthermore, the attachment monofilament was not present in the implant.Without the return and evaluation of the pusher and monofilament, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the pusher and monofilament, the reported event is considered non-verifiable.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142748000
• MDR Report Key: 15192342
• Report Number: 2032493-2022-00304
• Device Sequence Number: 5634198
• Product Code: KRD
• UDI-Device Identifier: 00810170017919
• UDI-Public: (01)00810170017919(11)211201(17)261130(10)0000131165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/25/2022

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 Model Number: 45-480415-L
• Device Catalogue Number: 45-480415
• Device Lot Number: 0000131165
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG