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

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	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the embolization of the rima during a pre-fontan case.The physician attempted to retract the coil back into the microcatheter, but the coil detached in the microcatheter.The physician was able to retrieve the detached coil by clamping the catheter and removing the system.The physician completed the case by using two coils.No harm to the patient.
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.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.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant damaged, deformed, separated from the pusher, and partially stuck within the returned microcatheter.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 damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was found flattened at 23cm and 27cm from proximal tip of strain relief, which may have caused or contributed to the separation of the coil from the pusher.

• 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 ; 7142478000
• MDR Report Key: 18842164
• Report Number: 2032493-2024-00188
• Device Sequence Number: 7486020
• Product Code: KRD
• UDI-Device Identifier: 00842429118085
• UDI-Public: (01)00842429118085(11)231017(17)280930(10)0000444817
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 0000444817
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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