MAUDE Adverse Event Report: MICROVENTION INC. HYDROSOFT-3D-AV; DEVICE, NEUROVASCULAR EMBOLIZATION,

Model Number	100103HFRM-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
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.It was stated that the device is available for evaluation, but it has not yet been returned to the manufacturer.The alleged issue could not yet be confirmed.If the device is received, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as potential complication associated with use of the device.
Event or Problem Description
It was reported that when the coil was moved into the aneurysm for positioning, it unintentionally detached in the microcatheter.The coil was removed from the patient and was replaced with a competitor's coil and the procedure was completed successfully.There was no reported injury or intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system found the black pet damaged, the pusher bent at the proximal end, and the implant separated from the pusher.The implant was not returned for evaluation; furthermore, the attachment monofilament was not present in the pusher.Without the return and evaluation of the implant and monofilament, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the implant and monofilament, the reported event is considered non-verifiable.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.Additional information was received that confirmed the implant and the pusher wire were completely removed from the patient's body.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION,
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15088947
• Report Number: 2032493-2022-00287
• Device Sequence Number: 5049302
• Product Code: HCG
• UDI-Device Identifier: 00816777026446
• UDI-Public: (01)00816777026446(11)211213(17)261130(10)0000136132
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2022

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: 100103HFRM-V
• Device Catalogue Number: 100103HFRM-V
• Device Lot Number: 0000136132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 52 KG