MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE HYDRO; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	45-450815
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
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 reported available for return but has not yet been received.Therefore, at this time, the product analysis could not be performed and the alleged product issue cannot be verified.If the device if the device or additional new information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the embolization coil was used in conjunction with an evar procedure.Internal iliac branch measured around 9cm distally with increasing diameter proximally.Reportedly, the coil experienced extreme resistance in the 4fr 65cm angled microcatheter from another manufacturer and could not be advanced.The microcatheter was exchanged for a 5fr 100cm angled catheter with no real improvement.The coil unraveled and unintentionally detached in the microcatheter.The coil was successfully removed with the catheter.Use of coils was aborted with only one coil placed and the physician decided to continue without full embolization.Only 1 of 5 coils were deployed successfully.Anatomy was normal with no tortuosity.No report of harm or injury to the patient and described as "normal.".
Additional Manufacturer Narrative
The device associated with this report (2032493-2023-00770) was used during the same procedure referenced in mfr.Reports# 2032493-2023-00771, 2032493-2023-00772 and 2032493-2023-00773.Summary of device evaluation: the investigation of the returned coil system found the strain relief damaged, and the implant damaged, deformed, and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament 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 implant to separate from the pusher.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.The microcatheter used in the procedure was found to be in good condition with no observable damage/kinking that would have caused or contributed to the reported event.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: DEVICE VASCULAR FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17054516
• Report Number: 2032493-2023-00770
• Device Sequence Number: 7039337
• Product Code: KRD
• UDI-Device Identifier: 00810170014949
• UDI-Public: (01)00810170014949(11)220201(17)270131(10)0000153404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 45-450815
• Device Catalogue Number: 45-450815
• Device Lot Number: 0000153404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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