MAUDE Adverse Event Report: AZUR-35 DETACHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

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	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported available for return but has not yet been received.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the embolization coil implant was used to treat a patient with an unruptured abdominal internal iliac artery aneurysm.The coil was deployed as third coil via an angiographic catheter without the use of a microcatheter.During placement of the third coil, significant resistance was encountered during advancement.Despite repositioning the catheter, further advancement remained impossible.While attempting to withdraw, the coil prematurely detachment in angiographic catheter.The procedure was discontinued due to the inability to complete embolization.Prior to the detachment of this coil, two coils of the same model had already been deployed for embolization.Angiography confirmed that the embolization effect had been achieved and no additional coils were implanted thereafter.The vascular anatomy may have contributed to the detachment of the coil.The patient was in stable condition.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h6, h11 (device evaluation conclusion).Investigation conclusion: a one-second angiographic video was provided for review.It is not labeled as to date or time.It is an un-subtracted ap view centered over the right pelvis and sacrum.A short arterial contrast injection is being made into the right external iliac artery from a short right femoral sheath.There is an approximately 2cm atherosclerotic aneurysm at the bifurcation of the right internal and right external iliac arteries.The right internal iliac artery is occluded by coils about 5 cm from its origin.The inferior end of an aortic stent is seen at the upper edge of the image.A left femoral sheath is in place.Wires are seen passing from both sheaths into the aortic stent; their distal ends are not on the image.This video did not explain why there was resistance during advancement or why the premature detachment occurred.The investigation of the returned coil system found the pusher bent, the outer sleeve damaged at the distal end, and the strain relief damaged, which is consistent with the device causing or contributing to the reported resistance within the catheter as described in the reported complaint.The implant was found kinked at the proximal section and separated from the pusher with no indication of the use of a detachment controller on the pusher's heater coil.The investigation found the pusher¿s monofilament with a tensile break shape at the tip which is consistent with the device experiencing 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 pusher and implant damage, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 23065119
• Report Number: 2032493-2025-90491
• Device Sequence Number: 9680532
• Product Code: KRD
• UDI-Device Identifier: 00810170015007
• UDI-Public: (01)00810170015007(11)240606(17)290531(10)0000622382
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 45-451230
• Device Lot Number: 0000622382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOGRAPHIC CATHETER (UNKNOWN).
• Patient Age: 68 YR
• Patient Sex: Male