MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; PERIPHERAL

Model Number	45-880035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.
Event or Problem Description
It was reported that the coil broke off from the pusher wire inside the microcatheter.The operator was twisting and pushing the coil into the pack and it broke off.They were able to stick another wire into the microcatheter and push it into the pack.This was the last coil deployed and the case was finished without any incident.No injury to the patient.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher strain relief damaged without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.Further inspection of the pusher found the proximal connector kinked.The implant was not returned for evaluation.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 kinked pusher, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
See h11.

• Brand Name: HP8 AZUR HYDROPACK 18
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 22515978
• Report Number: 2032493-2025-90324
• Device Sequence Number: 15591211
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: (01)00842429118061(11)250404(17)300331(10)0001053366
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 0001053366
• Was Device Available for Evaluation?: No
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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
• Patient Sex: Unknown