MAUDE Adverse Event Report: MICROVENTION INC HYDROSOFT-3D; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	100208HFRM-V-3D-A2
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 missing implant, and incident as described 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 originally reported the introducer failed to detect the insertion of the coil inside.The coil could not be used.Additional information received clarified that there was no coil at the distal part of the pusher.Another coil was used to complete the procedure.Patient status is good; there was no report of patient injury or consequence.No other clarification was provided.
Additional Manufacturer Narrative
This report represents correction to g6 / type of report on the mdr 2032493-2025-00198 previously submitted.The g6 type of report should have been noted as "initial" not a "5-day report.".The correction to g6 does not have any impact on the other data submitted on earlier reports.Other than g6, the data stand as previously submitted.
Event or Problem Description
No additional information was received.This report represents corrections to g6 on the mdr previously submitted.
Additional Manufacturer Narrative
Investigation conclusion: the reported complaint is unconfirmed.The investigation of the returned coil system found the implant deformed at the distal end; however, the implant coil was found to still be attached to the pusher upon receipt.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant deformation, but this condition is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
No other clarification was provided, however device was received and evaluated.Please see d10, h6 and h11.

• Brand Name: HYDROSOFT-3D
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21521232
• Report Number: 2032493-2025-00198
• Device Sequence Number: 9712682
• Product Code: HCG
• UDI-Device Identifier: 00816777026521
• UDI-Public: (01)00816777026521(11)230605(17)280531(10)0000375174
• 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,Followup
• Report Date (Section B): 04/04/2025

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: 100208HFRM-V-3D-A2
• Device Lot Number: 0000375174
• 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): Five-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 02/24/2025; 03/14/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/06/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown