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

Model Number	100728HFRM-V-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	02/20/2022
Type of Reportable Event	Serious Injury
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 investigation of the returned coil system found the implant severely stretched inside the microcatheter and to be attached to pusher with no signs of activation on the heater coil.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.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complication associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization of aneurysm, the coil was positioned for desirable placement.The coil became stuck within the microcatheter, stretched and could not be withdrawn.After several attempts, the coil separated from the delivery pusher.The coil was removed using a snare device successfully.No harm or injury to the patient, who was reported to be doing fine.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
This supplemental report is being submitted to only correct information in sections: b1, b2 and h1.

• Brand Name: HYDROFRAME-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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13861137
• Report Number: 2032493-2022-00101
• Device Sequence Number: 20169874
• Product Code: HCG
• UDI-Device Identifier: 00816777023575
• UDI-Public: (01)00816777023575(11)180116(17)221231(10)1801161W
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 100728HFRM-V-A2
• Device Catalogue Number: 100728HFRM-V
• Device Lot Number: 1801161W8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown