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

Model Number 100515HFIL-V-A2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance's 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 not returned to the manufacturer for analysis.Procedural or medical imaging were not provided.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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during a coil embolization treatment , the coil prematurely detached inside the microcatheter with the remaining half of it inside the aneurysm.A competitor control wire was used to push the coil's proximal portion back into the aneurysm successfully.There was no adverse impact to the patient.

• Brand Name: HYDROFILL-10-AV
• Type of Device: DEVICE, NEUROVASCULAR 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: 15781364
• MDR Text Key: 303561519
• Report Number: 2032493-2022-00522
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023308
• UDI-Public: (01)00816777023308(11)220907(17)270831(10)0000257128
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 100515HFIL-V-A2
• Device Catalogue Number: 100515HFIL-V
• Device Lot Number: 0000257128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female