MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; COILS

Model Number	7110-0208-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician was performing an l acomm embolization case.Tn coils#1-10 were successfully deployed without issue with headway duo#1.The physician inserted an aristotle 14 guidewire, after using the guidewire several times to re-position during the case, with headway duo#1 after coil#10 was deployed to re-position once again.The aristotle 14 would not advance into the headway duo#1 (b)(4).The aristotle 14 was removed, and a synchro soft guidewire was used without issue to re-position.Procedure continued and then coil#11 which would not advance into the hub of the headway duo #1, tn coil#11 was set aside and a new headway duo#2 was opened and case continued with coil#11 being inserted without issue.Tn coil#12 was inserted into headway duo#2 and would not advance.Coil#12 was set aside, and a new coil was chosen.Tn coil#13 would also not advance into headway duo#2.Both headway duo#2 and coil#13 were set aside for return.Headway duo#3 was opened and tn coil#14 and #15 inserted without issue.Tn coil#16 would not advance in headway duo#3 (b)(4).Tn coil#17 opened and deployed without issue.Tn coil#18 advanced into headway duo#3 without issue but would not fully enter aneurysm due to resistance to advance, upon an attempt to remove coil and re-position coil#18, coil#18 prematurely detached inside body and headway duo#3.The physciain attempted to remove coil#18 and headway duo#3 as a system, but coil#18 remained with only headway duo#3 being removed.The physician then opened a headway 21 and embotrap to remove coil#18 successfully.Case was then stopped with no further intervention.No injury 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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant separated from the pusher, stretched, broken at the distal section, and partially stuck within the introducer.The distal portion of the implant was not returned for evaluation.Further investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing forces that exceeded the tensile 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 implant damage, but the damage is consistent with the device experiencing forces that exceeded its yield and tensile strengths.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
See h10.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 23539137
• Report Number: 2032493-2025-90649
• Device Sequence Number: 13164129
• Product Code: HCG
• UDI-Device Identifier: 00816777025401
• UDI-Public: (01)00816777025401(11)210607(17)260531(10)2106071W6
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• 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): 12/22/2025

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 Expiration Date: 05/31/2026
• Device Model Number: 7110-0208-3D-A2
• Device Lot Number: 2106071W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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: Female