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

Model Number	45-880035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Serious 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.
Event or Problem Description
As reported: during embolization procedure, the coil detached prematurely while being placed inside the patient.The dr had to go in with a snare to retrieve the coil.No patient injury reported.Case was completed using a 20cm hydropack instead.Was able to deploy it successfully without issues.Procedure was completed successfully.Patient is fine, procedure was a success.
Event or Problem Description
As reported: during embolization procedure, the coil detached prematurely while being placed inside the patient.The dr had to go in with a snare to retrieve the coil.No patient injury reported.Case was completed using a 20cm hydropack instead.Was able to deploy it successfully without issues.Procedure was completed successfully.Patient is fine, procedure was a success.
Additional Manufacturer Narrative
Correction: corrected "report type" and "outcome attributed to adverse event" in section b.Items returned for evaluation: -pusher.-implant.Items not returned for evaluation: -introducer.-shrink lock.-dispenser hoop.-microcatheter.The visual analysis of the returned items found that the implant was not attached to the pusher but no signs of activation was observed on the pusher heater coil, and the pusher was kinked at the distal section.The implant was returned stretched and entangled at the proximal section and separated from the pusher.The investigation found the pusher's monofilament broken, which indicates that the device experienced a tensile break.The investigation of the returned coil system found the pusher kinked at the distal section, and the implant stretched and entangled at the proximal section and separated from the pusher; however, no indications of activation using a detachment controller were 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 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 returned for evaluation, 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: 19911444
• Report Number: 2032493-2024-00594
• Device Sequence Number: 20626566
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: (01)00842429118061(11)240117(17)281231(10)0000498483
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 45-880035
• Device Lot Number: 0000498483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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