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

Model Number	100206HFRM-V-3D-A2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the physician was using coils in a parent vessel occlusion procedure.The anatomy was tortuous to the target position however 2 previous coils had already been inserted successfully.When the physician tried to detach the coil, it wouldn't detach but he did see the coil begin to unwind as he manipulated the delivery wire.The coil unwound inside the guide catheter when he decided he needed to remove the guide complete with the stretched coil inside.The stretched coil then broke at the distal end of the guide and left a fine unraveled filament back down the vessel.He managed to push the remainder of this stretched segment back up into the coil ball where it became secure and caused no issue to the treatment of the patient.Patient was successfully treated by the procedure despite the stretched coil.The stretched section became part of the coil ball used as the treatment.No injury to the patient.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant to be separated from the pusher.The implant was not returned for evaluation.Further inspection found the pusher body coil to be stretched and entangled at the distal section, which is consistent with the condition described in the reported event.The pusher's monofilament showed 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 stretched pusher body coil, but this damage is consistent with the device experiencing forces exceeding the pusher's yield strength.
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 ; 7142478000
• MDR Report Key: 20860704
• Report Number: 2032493-2024-00875
• Device Sequence Number: 4069840
• Product Code: HCG
• UDI-Device Identifier: 00816777026514
• UDI-Public: (01)00816777026514(11)240920(17)290831(10)0000711136
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100206HFRM-V-3D-A2
• Device Lot Number: 0000711136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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