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

Model Number	45-880020
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported: embo bleed case of vessel off celiac artery, 5fr right femoral artery access followed by catheter, and then followed by 0.021 microcatheter to target area.Various coils deployed before reported coil was inserted.Coil was inserted into microcatheter without incident.Coil placement was not satisfactory for physician and retrieval of the coil was attempted.It was discovered that the coil had detached from the delivery system.The coil traveled to a non-target area.A small snare was inserted to remove the hydropack coil that traveled to an unintended target, successful removal of hydropack via snare.Patient stable post procedure.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant coil separated from the pusher, stretched and broken at the proximal section, and was returned entangled on a snare, which is consistent with the condition of the implant described in the reported event.However, the attachment monofilament was not present in the implant; furthermore, the portion of the implant proximal to the break site and the pusher were not returned for evaluation.Without the return and evaluation of the pusher and monofilament, the investigation is unable to determine the mode of separation (i.E., unintentional vs normal detachment using a detachment controller).The investigation could not verify the mode of implant separation due to the absence of the pusher and monofilament.Furthermore, no procedure imaging/videos were provided for review; therefore, the investigation could not determine if the implant migrated to a non-target area as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched and broken implant, but the damage is consistent with the device experiencing forces exceeding the implant's yield and tensile strength during removal with the snare.

• 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: 25050905
• Report Number: 2032493-2026-00292
• Device Sequence Number: 10410855
• Product Code: KRD
• UDI-Device Identifier: 00842429118054
• UDI-Public: 00842429118054
• 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
• 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): 06/16/2026

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: 45-880020
• Device Lot Number: 0001115775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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: MIK CATHETER.; TRUSELECT 0.021 MICROCATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown