MAUDE Adverse Event Report: MICROVENTION, INC. AZUR HYDROPACK 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-880010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: deep venous arterialization (dva) procedure of right foot via right femoral artery and pedal access, successful dva performed.Arterial flow in pedal vein confirmed by physician.It was decided by physician to embolize a branch coming off main vessel near the ankle of the target foot.Catheter, 135cm 0.018, advanced to target area.Detachable coil advanced and successfully deployed at target, which had newly acquired arterial flow.Hydropack advanced to target area.Detacher connected to hydropack, no green light observed on detachment device.Detachment device was disconnected and reattached 3 additional times with the same result.Physician decided to remove the hydropack.Physician discovered the hydropack was detached from the delivery system when removal of the hydropack was attempted.Hydropack was deployed near target area.Hydropack in question was observed moving into non-target vessel by the physician.Physician decided to secure the hydropack against the vessel wall using a competitor's covered stent of unknown size.Post procedure images obtain by the physician.Patient stable post procedure as per physician.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: AZUR HYDROPACK 18
• 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: 24749850
• Report Number: 2032493-2026-00211
• Device Sequence Number: 15630249
• Product Code: KRD
• UDI-Device Identifier: 00842429118047
• UDI-Public: (01)00842429118047(11)250325(17)300228(10)0001044887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-880010
• Device Lot Number: 0001044887
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 135CM .018 NAVICROSS CATHETER; DETACHER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown