MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100154H2HS-V-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a daca aneurysm, an embolization coil implant encountered resistance during advancement and detached within the microcatheter during retraction.The coil the was removed in its entirety along with the microcatheter.There was no reported 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 investigation of the returned coil system found the pusher stuck inside the returned microcatheter, the implant deformed at proximal and to be attached to the pusher.The pusher was removed from the microcatheter and found the pusher stretched and broken at the middle section of the body coil.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 retraction forces over specification.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

• Brand Name: HYDROSOFT-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 13007930
• Report Number: 2032493-2021-00488
• Device Sequence Number: 1766291
• Product Code: HCG
• UDI-Device Identifier: 00816777022844
• UDI-Public: (01)00816777022844(11)181031(17)230930(10)1810311WR
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 09/30/2023
• Device Model Number: 100154H2HS-V-A2
• Device Catalogue Number: 100154H2HS-V
• Device Lot Number: 1810311WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Female