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

Model Number	100208HFRM-V-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an embolization coil implant encountered resistance during advancement in a microcatheter.The coil became stuck and was removed.During removal, the implant detached from the pusher.The coil was replaced an the procedure was completed successfully with another coil.There was no patient injury or intervention.
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 analysis, however it has not yet been received.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.The instructions for use (ifu) identifies premature detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Items returned for evaluation: pusher.Implant.Introducer.Items not returned for evaluation: dispenser hoop.Shrink lock.Microcatheter.V-grip.The visual analysis of the returned items found the implant coils severely stretched and tangled, but still attached to the pusher.The pusher body coil was found stretched and broken at the transition area.The investigation of the returned coil system found the implant coils severely stretched and tangled, but still attached to the pusher.However, the pusher body coil was found stretched and broken at the transition area, which is consistent with the alleged product issue.The broken condition of the pusher is consistent with the device experiencing excessive force that exceeded the device's tensile strength, resulting in the pusher breaking.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 forces over specification.
Event or Problem Description
It was reported that an embolization coil implant encountered resistance during advancement in a microcatheter.The coil became stuck and was removed.During removal, the implant detached from the pusher.The coil was replaced an the procedure was completed successfully with another coil.There was no patient injury or intervention.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 17455834
• Report Number: 2032493-2023-00877
• Device Sequence Number: 14127769
• Product Code: HCG
• UDI-Device Identifier: 00816777026521
• UDI-Public: (01)00816777026521(11)220210(17)270131(10)0000157531
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100208HFRM-V-3D-A2
• Device Lot Number: 0000157531
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 80 KG