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

Model Number	7110-0203
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	09/21/2022
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.The coil was successfully implanted in the patient and was not returned to the manufacturer for analysis.Additionally, the pusher was discarded at the user facility and not returned to the manufacturer for evaluation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.
Event or Problem Description
It was reported that during deployment of the 3rd coil into a ruptured acomm aneurysm, resistance was encountered.The coil detached well; however, when the physician withdrew the pusher wire, a very thin filar appeared at proximal end of the microcatheter that eventually broke off inside the microcatheter.The pusher wire and microcatheter were successfully removed from the patient.The case was completed, and the coil mass looked good.There was no adverse impact to the patient.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15547457
• Report Number: 2032493-2022-00389
• Device Sequence Number: 1945519
• Product Code: KRD
• UDI-Device Identifier: 00816777025371
• UDI-Public: (01)00816777025371(11)220627(17)270531(10)0000214025
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: 7110-0203
• Device Catalogue Number: 7110-0203
• Device Lot Number: 0000214025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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