MAUDE Adverse Event Report: MICROVENTION INC. HYDROSOFT-3D-AV; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	7110-0310-3D-A2
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during preparation, the doctor noticed fibers on the coil.The coil was never used on the patient.
Additional Manufacturer Narrative
Investigation conclusion: the customer provided an image showing a fiber positioned between the introducer and the shrink lock, which is consistent with the alleged product issue.However, the investigation of the returned coil system did not identify a fiber on the device or inside the returned packaging.As the fiber seen in the provided image was absent from returned device, the investigation could not perform ftir (fourier transform infrared) analysis to determine the origin of the fiber.
Event or Problem Description
Additional information received that provided an image and was reviewed.

• Brand Name: HYDROSOFT-3D-AV
• 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: 20887300
• Report Number: 2032493-2024-00884
• Device Sequence Number: 15429446
• Product Code: KRD
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)240726(17)290630(10)0000663218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• 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): 01/31/2025

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: 7110-0310-3D-A2
• Device Lot Number: 0000663218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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