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

Model Number	100154HFRM-V-3D-A2
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physician phone: (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 coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of an aneurysm, an embolization coil implant did not detach.Upon retraction of the device, the implant and delivery pusher began to stretch and the implant detached in the guiding catheter.The physician successfully pushed the coil into the aneurysm using a 0.35" wire.There was no reported patient injury or intervention.The patient is reported to be "okay.".
Additional Manufacturer Narrative
The mv coil system was not returned for evaluation.The customer returned a part of the "ptfe liner" from the microcatheter used in the procedure.This material is not apart of the mv coil system used in the procedure.

• Brand Name: HYDROSOFT 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11926050
• Report Number: 2032493-2021-00214
• Device Sequence Number: 19628543
• Product Code: HCG
• UDI-Device Identifier: 00816777026477
• UDI-Public: (01)00816777026477(11)181001(17)230930(10)1810015P6
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 09/30/2023
• Device Model Number: 100154HFRM-V-3D-A2
• Device Catalogue Number: 100154HFRM-V
• Device Lot Number: 1810015P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1