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

Model Number	100206HFRM-V-3D-A2
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: mca aneurysm treatment, usual coil usage started.During preparation of coil, they realised some wire debris on the hypotube.Started the access into the microcatheter and the device was detached from the pusher.Removed all parts and collected.Patient treated with other coils successfully.Patient is in good condition.
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, introducer.Items not returned for evaluation: microcatheter.The visual analysis of the returned device found the implant returned stretched at the proximal section but still attached to the pusher.The pusher was observed to be in good condition with no kinks, damage, or loose components.The investigation of the returned coil system found the implant coil stretched at the proximal section; however, the pusher was in good condition and showed no signs of kinks, damage, or loose components that would resemble the "debris" described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant stretching, but stretching is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
As reported: mca aneurysm treatment, usual coil usage started.During preparation of coil, they realised some wire debris on the hypotube.Started the access into the microcatheter and the device was detached from the pusher.Removed all parts and collected.Patient treated with other coils successfully.Patient is in good condition.Additional information received: "debris¿ found outside the hub before access was thought to be a piece of metal, possibly from the coil.It was not lead wires separation, they thought it was some coil producing parts because they found it on the dispenser tube.When the pusher detached, it was further inside the microcatheter.One third is in the aneurysm, other is in the microcatheter.Physician was able to retract to the guide and remove the whole device.

• 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: 21028320
• Report Number: 2032493-2024-00941
• Device Sequence Number: 4008154
• Product Code: KRD
• UDI-Device Identifier: 00816777026514
• UDI-Public: (01)00816777026514(11)240921(17)290831(10)0000711716
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 100206HFRM-V-3D-A2
• Device Lot Number: 0000711716
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER
• Patient Age: 73 YR
• Patient Sex: Female