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

Model Number	45-880060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peripheral coil device was used in an unspecified procedure.The coil detached in the microcatheter and was removed.There was no patient harm or intervention reported.No other information was provided.
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 was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the implant stretched with the monofilament exposed, damaged, and separated from the pusher.The pusher was not returned for evaluation.The investigation found the implant'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 stretched implant, but the damage is consistent with the device experiencing forces exceeding the implant'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
Additional information received notes the procedure was completed by taking the microcatheter out of the patient and the coil was suctioned out of the microcatheter with a syringe to pull it out.The device was received and evaluated.

• 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: 22733714
• Report Number: 2032493-2025-90376
• Device Sequence Number: 20920867
• Product Code: KRD
• UDI-Device Identifier: 00842429118085
• UDI-Public: (01)00842429118085(11)241120(17)291031(10)0000778817
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/08/2025

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: 45-880060
• Device Lot Number: 0000778817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown