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

Model Number	100204HFRM-V-3D-A2
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
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 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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that the coil stretched in the microcatheter.Additional information indicated, while placing the coil in the aneurysm, the microcatheter moved slightly against the aneurysm wall, which prevented the rest of the coil being deployed.While withdrawing the coil back into the microcatheter, slight resistance was felt initially, but then this eased.It was at this point the operator realized (assumed) the coil had stretched, but he continued to pull, causing the pusher wire and coil to separate.No patient harm was reported.The patient was reported fine and well.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, and microcatheter.Items not returned for evaluation: n/a.The pusher was returned with a stretched and broken bodycoil and stuck within the microcatheter.The microcatheter was returned cut at the distal end with the coil stretched.Further inspection found the implant to be still attached to the pusher.The investigation of the returned coil system found the pusher bodycoil stretched, broken and stuck within the microcatheter.However, the implant was found to still be attached to the distal portion of the pusher.The microcatheter was returned cut with the coil stretched.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing retraction forces that exceeded the strength of the pusher coil.
Event or Problem Description
The product was received for evaluation.

• 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: 20868564
• Report Number: 2032493-2024-00877
• Device Sequence Number: 18343137
• Product Code: KRD
• UDI-Device Identifier: 00816777026507
• UDI-Public: (01)00816777026507(11)240810(17)290731(10)0000675899
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 100204HFRM-V-3D-A2
• Device Lot Number: 0000675899
• Was Device Available for Evaluation?: Yes
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown