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

Model Number	100310HFRM-V-3D-A2
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 returned to the manufacturer for evaluation.The analysis is currently underway.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment of an aneurysm, the coil appeared to detach; however, it actually detached within the microcatheter while removing the delivery system.The coil and microcatheter were withdrawn as a system without incident.The procedure was completed successfully with other coils.The patient awoke from the procedure with no issues.There was no report of intervention or injury to the patient.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant severely stretched at proximal/distal end, stuck inside the returned microcatheter, and to be separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a stretched tail/tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament, causing the implant to separate from the pusher.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.

• Brand Name: HYDROSOFT 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11926048
• Report Number: 2032493-2021-00216
• Device Sequence Number: 3181794
• Product Code: HCG
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)200803(17)250731(10)2008035W6
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 07/31/2025
• Device Model Number: 100310HFRM-V-3D-A2
• Device Catalogue Number: 100310HFRM-V
• Device Lot Number: 2008035W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1