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

Model Number	100254HFRM-V-3D-A2
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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 returned to the manufacturer for evaluation.The investigation is ongoing.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during embolization of an aneurysm of the anterior communicating artery, an embolization coil implant encountered friction in the microcatheter.The coil detached within the catheter upon attempted removal and the physician removed the detached portion through the hub.There was no reported injury or intervention.
Additional Manufacturer Narrative
H10: evaluation summary: the coil implant was not returned.The microcatheter used in the procedure was not evaluated as a part of this evaluation; therefore, the investigation could not determine if it had caused or contributed to the reported complaint.The investigation of the returned coil delivery system found the implant to be separated from the pusher.The pusher and introducer were returned intact with no notable damage.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the monofilament broken at the attachment bond, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant and monofilament to separate from the pusher during extraction.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11971213
• Report Number: 2032493-2021-00226
• Device Sequence Number: 19680139
• Product Code: HCG
• UDI-Device Identifier: 00816777026545
• UDI-Public: (01)00816777026545(11)200814(17)250731(10)2008145P6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 12/31/2025
• Device Model Number: 100254HFRM-V-3D-A2
• Device Catalogue Number: 100256HFRM-V
• Device Lot Number: 2101295W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1