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

Model Number	7110-0153-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 was stated to be available for return to the manufacturer for analysis.However, the device has not been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that a stent-assisted coiling of an aneurysm of the left anterior choroidal artery was being performed when the microcatheter began to lose position.An embolization coil implant was being deployed at the time.It was attempted to push the implant back into the aneurysm but the implant detached unexpectedly.The implant was stuck between the stent and the vessel wall.The patient was reported to be "fine otherwise" and that the physician was able to finish the case.There was no intervention.
Additional Manufacturer Narrative
Items returned for evaluation: pusher.Items not returned for evaluation: implant; introducer; shrink lock; dispenser hoop; microcatheter.The visual analysis of the returned device found that the pusher bodycoil was broken at the transition area, and the proximal connector was kinked.The distal portion of the pusher and the implant were not returned for evaluation.The investigation of the returned coil system found the proximal connector kinked, and the pusher bodycoil broken at the transition area.The implant and the distal portion of the pusher were not returned for evaluation.Without the return and evaluation of the implant and attachment 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, the reported event is considered non-verifiable.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.
Event or Problem Description
It was reported that a stent-assisted coiling of an aneurysm of the left anterior choroidal artery was being performed when the microcatheter began to lose position.An embolization coil implant was being deployed at the time.It was attempted to push the implant back into the aneurysm but the implant detached unexpectedly.The implant was stuck between the stent and the vessel wall.The patient was reported to be "fine otherwise" and that the physician was able to finish the case.There was no intervention.

• Brand Name: HYDROSOFT 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 20298177
• Report Number: 2032493-2024-00709
• Device Sequence Number: 8686630
• Product Code: KRD
• UDI-Device Identifier: 00816777025340
• UDI-Public: 00816777025340
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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: 7110-0153-3D-A2
• Device Catalogue Number: 7110-0153
• Device Lot Number: 0000397299
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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 Sex: Unknown