MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7110-0817-A2
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	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was placed in the aneurysm and detached; however, during retrieval of the pusher wire post detachment, the physician noticed a strand of coil still connected to the wire.The majority of the coil detached and was implanted, but one strand / coil fiber remained attached to the pusher wire.Four (4) more coils were placed after, and the procedure was successfully completed.There was no reported injury or harm to the patient reported.
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 returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
The investigation of the returned coil system found, the pusher severely stretched and broken at the distal section with lead wires exposed and broken.The implant was not returned for evaluation.However, the pusher's monofilament profile indicated, the implant was successfully detached from thermal activation, using a detachment controller.No strand of the implant coil was found attached to the pusher, as described in the reported event.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: HYDROFRAME 10 ADVANCED
• 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: 15442846
• Report Number: 2032493-2022-00369
• Device Sequence Number: 5673443
• Product Code: HCG
• UDI-Device Identifier: 00816777023735
• UDI-Public: (01)00816777023735(11)200109(17)241231(10)2001091WF
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Expiration Date: 12/31/2024
• Device Model Number: 7110-0817-A2
• Device Lot Number: 2001091WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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