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	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hydropack would not detach with the controller.The controller detached 2 other coils prior to the hydropack.The hydropack the controller showed a green light and the went to red when the button was pressed.Several attempts were made after the gold portion of the wire was cleaned.When the coil was retracted it detached in the microcatheter.The event did not result in patient injury.
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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.
Additional Manufacturer Narrative
Investigation findings items returned for evaluation: -pusher -implant -introducer -microcatheter -controller items not returned for evaluation: -n/a the visual analysis of the returned device found that the implant was not attached to the pusher, and the pusher exhibited lead wire separation from the middle to the proximal section.Further inspection found that the green lead wire was broken.No functional testing to further assess the alleged detachment issue could be performed due to the condition of the pusher.The implant was found to be separated from the pusher and stuck within the microcatheter.The investigation found that the pusher's monofilament was broken, which indicates that the device experienced a tensile break.The returned microcatheter was not found to be damaged.Controller investigation: the device was tested for output voltage and output time.The battery voltages and board voltage were at 12.32v, 12.39v, 12.39v and 24.71v.The device met the output specification.The light and audio sequences functioned normally.Device performed as intended.The investigation of the returned coil system found the pusher with lead wire separation from the middle to the proximal section with the green lead wire broken, and the implant separated from the pusher and stuck within the microcatheter; however, no indications of activation using a detachment controller was found on the pusher heater coil.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 broken green lead wire would have resulted in the alleged non-detachment if this condition was present at the time of the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the lead wire separation and lead wire break, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.
Event or Problem Description
It was reported that the hydropack would not detach with the controller.The controller detached 2 other coils prior to the hydropack.The hydropack the controller showed a green light and the went to red when the button was pressed.Several attempts were made after the gold portion of the wire was cleaned.When the coil was retracted it detached in the microcatheter.The event did not result in patient injury.

• 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
• MDR Report Key: 20671217
• Report Number: 2032493-2024-00829
• Device Sequence Number: 12887499
• Product Code: KRD
• UDI-Device Identifier: 00842429118085
• UDI-Public: (01)00842429118085(11)240613(17)290531(10)0000628605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/16/2024

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: 0000628605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AZUR CX35 LOT 0000559133.; AZUR CX35 LOT 0000580903.; DETACHMENT CONTROLLER.; PROGREAT 2.4 LOT 230424.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White