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

Model Number	45-880035
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
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 has been 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: primary catheter inserted in direction of target.Microcatheter was advanced to target area through primary catheter.Prior to coil in question, a 10cm hydropack was successfully deployed to target area.Coil in question was flushed in standard fashion by scrub tech.Doctor placed coil introducing sheath next to proximal portion of microcatheter.Tech noticed resistance upon insertion and conferred with doctor.Doctor decided it would be best to remove coil to inspect.Coil was not in standard shape upon inspection, coil breakage was suspected by the doctor.A new 35cm hydropack was opened and successfully deployed.Other hydropack coils inserted and successfully deployed afterwards.Successful gda embolization as per doctor after angiography performed.A seal was used for right common femoral closure.Patient stable post procedure.Procedure performed: gda embolization via right common femoral artery.
Event or Problem Description
As reported: primary catheter inserted in direction of target.Microcatheter was advanced to target area through primary catheter.Prior to coil in question, a 10cm hydropack was successfully deployed to target area.Coil in question was flushed in standard fashion by scrub tech.Doctor placed coil introducing sheath next to proximal portion of microcatheter.Tech noticed resistance upon insertion and conferred with doctor.Doctor decided it would be best to remove coil to inspect.Coil was not in standard shape upon inspection, coil breakage was suspected by the doctor.A new 35cm hydropack was opened and successfully deployed.Other hydropack coils inserted and successfully deployed afterwards.Successful gda embolization as per doctor after angiography performed.A seal was used for right common femoral closure.Patient stable post procedure.Procedure performed: gda embolization via right common femoral artery.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher; -implant; -introducer.Items not returned for evaluation: -microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher, and the pusher was kinked at the distal section.The implant was returned stretched, entangled, and separated from the pusher.The investigation found that the pusher's monofilament was 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, entangled, and separated from the pusher; 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 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 not 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: 20313664
• Report Number: 2032493-2024-00718
• Device Sequence Number: 8099728
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: (01)00842429118061(11)240229(17)290131(10)0000537413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/01/2024

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: 45-880035
• Device Lot Number: 0000537413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: MIKAELSSON CATHETER.; TRU-SELECT MICROCATHETER.
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White