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

Model Number	100208HFRM-V-3D-A2
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
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 has not yet been received by the manufacturer for evaluation.The instructions for use (ifu) identifies difficult coil detachment and premature coil detachment as potentials complications associated with use of the device.
Event or Problem Description
It was reported after placement of an embolization coil in an aneurysm, the coil could not be detached with the controller.During removal, the coil detached from the pusher wire.Both segments of the coil were removed without additional intervention.There was no reported patient injury.
Additional Manufacturer Narrative
The pusher was the only component received for evaluation.The pusher was returned without the implant attached.The pusher's proximal gold connector solder joint and distal solder joints were found intact with no notable damage.The monofilament was removed from the pusher body coil and displays a stretched tail profile at the tip, indicating tensile force was applied to the monofilament.The device was tested with a multimeter device and the pusher resistance registered a 41.5 ohm reading.The proximal connector was registering an intermittent "ol" reading with a series of ohm readings.The gold connector was tested with a lab-provided v-grip controller and red lights were flashing after the button was activated.The conditions or circumstances that led to the damaged monofilament could not be determined, but the damage is consistent with the device experiencing forces over specification during the procedure.The device experiencing non-detachment issues is due to the intermittent electrical resistance readings on the proximal gold connector.The device registering a resistance reading and open load readings at the same time is consistent with a device experiencing a short circuit.The root cause of the short circuit cannot be determined.

• Brand Name: HYDROSOFT 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10292584
• Report Number: 2032493-2020-00167
• Device Sequence Number: 2525851
• Product Code: KRD
• UDI-Device Identifier: 00816777026521
• UDI-Public: (01)00816777026521(11)191202(17)241130(10)1912021W6
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 100208HFRM-V-3D-A2
• Device Catalogue Number: 100208HFRM-V
• Device Lot Number: 1912021W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 95