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

Model Number	45-451230
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during embolization the coil was deployed through a catheter in a vein during a tipss procedure.The coil was deployed 1 to 2 centimeters when increased friction was noticed then it was discovered that the filament was broken, and the coil was detected in the catheter.The catheter was removed with the coil in it and a new catheter was used to finish the embolization without incident.There was no patient health damage.
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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature and difficult or delayed detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant to be separated from the pusher with deformed loops and the monofilament exposed; however, no indications of activation using a detachment controller was found on the pusher heater coil.Further inspection of the implant found the 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 not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• 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
• MDR Report Key: 17243474
• Report Number: 2032493-2023-00823
• Device Sequence Number: 15178018
• Product Code: KRD
• UDI-Device Identifier: 00810170015007
• UDI-Public: (01)00810170015007(11)201110(17)251031(10)2011105JG
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Expiration Date: 10/31/2025
• Device Model Number: 45-451230
• Device Catalogue Number: 45-451230
• Device Lot Number: 2011105JG
• Was Device Available for Evaluation?: Yes
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 1 MO
• Patient Sex: Female
• Patient Weight: 96 KG