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

Model Number	45-480620-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	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization case, the azur coil did not detach after it was deployed and positioned.Then the physician utilized the detachment controller again but the coil still did not detach.Reportedly, the coil unintentionally detached inside the microcatheter when it was attempted to withdraw the coil.The physician withdrew the catheter and flushed the catheter to remove the coil then continued the case by utilizing other coils.No report of harm or injury to the patient, who was reportedly stable and doing well.
Additional Manufacturer Narrative
A search for non-conformance's 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
Correction: d9 (yes, device available for evaluation).Additional information: h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the proximal gold connector bent, the pusher with lead wire separation, and the pusher stretched and broken in two parts at the distal end.The implant was returned stretched, but still attached to the pusher's heater coil with no signs of activation using a detachment controller.Furthermore, the investigation found the monofilament still attached to the implant.The monofilament was found with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the pusher to break in two parts.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.

• 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: 14219225
• Report Number: 2032493-2022-00170
• Device Sequence Number: 5359331
• Product Code: KRD
• UDI-Device Identifier: 00810170017957
• UDI-Public: (01)00810170017957(11)210505(17)260430(10)2105055JB
• 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): 04/12/2022

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: 04/30/2026
• Device Model Number: 45-480620-L
• Device Catalogue Number: 45-480620
• Device Lot Number: 2105055JB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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: 42 YR
• Patient Sex: Female