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

Model Number	10100515HFIL-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	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coil jailing procedure to treat a basilar aneurysm, the coil unintentionally detached in the microcatheter when it was approaching the aneurysm.The flow diverter was recaptured and the entire coil and catheter were removed successfully from the patient.No patient injury or intervention occurred.
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.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.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher damaged at the distal end, the pusher knotted, the hypotube bent at multiple areas, and the proximal connector kinked.The implant was returned stuck at the distal end of the microcatheter and separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.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.Correction: g4 added 510k number in section "pma/510(k)" h10 initial mdr duplicated sentence "it was stated that the device is available for evaluation, but it has not yet been returned to the manufacturer.The alleged issuecould not yet be confirmed.If the device is received, an investigation will be performed and a supplemental mdr will be submitted.".

• Brand Name: HYDROFILL-10-AV
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15154363
• Report Number: 2032493-2022-00302
• Device Sequence Number: 5323288
• Product Code: HCG
• UDI-Device Identifier: 00816777023308
• UDI-Public: (01)00816777023308(11)220421(17)270331(10)0000182804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113457
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 10100515HFIL-V
• Device Catalogue Number: 100515HFIL-V
• Device Lot Number: 0000182804
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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