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

Model Number	100206H2HS-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization treatment for a ruptured posterior communicating (pcom) aneurysm, the microcatheter was positioned inside the aneurysm over a traxcess wire.After deploying a couple of coils, resistance was felt while pushing the hydrosoft coil inside the microcatheter, and the physician decided to re-sheath the coil.After pulling back the pusher wire into the coil introducer sheath, it was observed the coil had detached inside the microcatheter and only the pusher wire was retrieved.A few runs revealed 90% aneurysm occlusion, so the physician decided to withdraw the microcatheter and stop the procedure.The patient was shifted to the icu post procedure and later discharged.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 evaluation but has not yet been returned.The reported 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 and difficult or delayed coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found that the pusher was returned without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.Further inspection found that the pusher body coil was broken at the transition area.Additionally, the implant was found to be stretched, separated from the pusher, and lodged inside the microcatheter.The investigation found the pusher's monofilament with a 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-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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17431292
• Report Number: 2032493-2023-00870
• Device Sequence Number: 8913696
• Product Code: HCG
• UDI-Device Identifier: 00816777022899
• UDI-Public: (01)00816777022899(11)220920(17)270831(10)0000262345
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100206H2HS-V-A2
• Device Lot Number: 0000262345
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 48 KG