MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-880035
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: during trans-caval embo procedure, a 018 x 150 cm catheter was able to cross the aortic sac, no other catheter was able to cross.Once the catheter reached where it needed to be, the catheter was flushed and loaded with the 35 cm hydropack.There were no issues until the coil reached the tip of the catheter, so the catheter was pulled back slightly.The coil was still unable to be pushed out.While puling the coil out, the pusher wire appeared detached from the coil.An attempt to flush in the coil was without success.An attempt to push the coil in with a wire was without success.The catheter was pulled out with the coil inside and access to the sac was lost due to this issue.The case was then called due to the amount of time it took to get the catheter into position and then losing access.The coil was strung out and pulled from the catheter.The patient¿s aneurysm was left untreated when the procedure was called.It is unknown if the patient was prescribed any medication.The patient was planned to be discharged and go home on the same day as the procedure.The plan is to have the patient get an additional ct in 3 months to see if the aneurysm sac is still growing and go from there.
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 device has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

• Brand Name: HP8 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: 25488431
• Report Number: 2032493-2026-00400
• Device Sequence Number: 9921905
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: 00842429118061
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• 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): 07/08/2026

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: 45-880035
• Device Lot Number: 0001476241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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: 018 X 150 CM NAVICROSS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White