MAUDE Adverse Event Report: MICROVENTION INC. HYDROFILL HELICAL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	100620HFIL-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an embolization coil implant encountered resistance in the microcatheter and then detached unexpectedly.There was no injury or intervention.The patient was reported to be "fine and well." another embolization coil implant encountered the same issue during the case and was reported under a separate medical device report.
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 analysis is currently ongoing.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher -introducer -dispenser hoop items not returned for evaluation: -implant -shrink lock -microcatheter the visual analysis of the returned device found that the implant was not attached to the pusher, and the pusher hypotube kinked at the middle section.The implant was not returned for evaluation.The introducer was returned undamaged.The introducer distal tip was found to be within specification (spec= 0.0180" -0.0005/+0.001).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 returned without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.Further inspection found the pusher hypotube to be kinked at the middle section.The implant was not returned for evaluation.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 pusher damage, but the damage is consistent with the device experiencing forces over specification.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.
Event or Problem Description
It was reported that an embolization coil implant encountered resistance in the microcatheter and then detached unexpectedly.There was no injury or intervention.The patient was reported to be "fine and well." another embolization coil implant encountered the same issue during the case and was reported under separate medical device report 2032493-2024-00683.

• Brand Name: HYDROFILL HELICAL
• 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: 20207961
• Report Number: 2032493-2024-00679
• Device Sequence Number: 6815450
• Product Code: KRD
• UDI-Device Identifier: 00816777024411
• UDI-Public: 00816777024411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 100620HFIL-V-A2
• Device Lot Number: 0000584157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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 Sex: Unknown