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	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a right pavm embolization procedure, the coil and microcatheter could not advance well when attempting to get into the vessel.While attempting to regain access into the target vessel, the coil was going to be recaptured into the delivery sheath by inserting a pusher wire, but the coil had a loose piece and prematurely separated while it was still inside the microcatheter.The coil and microcatheter were removed from the patient.The microcatheter was flushed, and it was used to finish the case.The procedure was completed successfully.The patient was discharged in stable condition.
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
The investigation of the returned coil system found the implant coil damaged, deformed, and stretched at the proximal end with the monofilament and implant gel exposed.The implant was returned still attached to the pusher.The pusher was returned with lead wire separation of approximately 120cm long from the proximal to the distal section, which is consistent with the "loose piece" observed when attempting to retract the pusher into the introducer as described in the reported event.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.
Event or Problem Description
See h11.

• 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: 19957616
• Report Number: 2032493-2024-00605
• Device Sequence Number: 13003512
• Product Code: KRD
• UDI-Device Identifier: 00842429118078
• UDI-Public: (01)00842429118078(11)240604(17)290531(10)0000619732
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 45-880050
• Device Lot Number: 0000619732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White