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

Model Number	45-880050
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite attempts made asking to return it.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and 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.
Event or Problem Description
It was reported that while a coil was being delivered during a coil embolization procedure, it advanced into a small branch just proximal to the target landing zone.The coil was attempted to be recaptured, but it prematurely detached.Upon further pulling back the pusher wire, the coil was found detached within the 4fr glide catheter.A.025 wire was inserted into the 4fr glide catheter, and it was advanced past the entrained coil.Another.014 wire was then advanced up to the distal part of the coil which successfully wedged the coil between the wires.Then, the 4fr glide catheter, coil and wires were retracted through the patient¿s body under fluro and were all successfully removed from the patient.The case was completed without any further incident.There was no reported patient injury.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant to be kinked, 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 implant damage, 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.

• 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: 21163949
• Report Number: 2032493-2025-00066
• Device Sequence Number: 18553453
• Product Code: KRD
• UDI-Device Identifier: 00842429118078
• UDI-Public: (01)00842429118078(11)240709(17)290630(10)0000648803
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/05/2025

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: 45-880050
• Device Lot Number: 0000648803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown