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

Model Number 7110-0931-A2

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/23/2022

Event Type  malfunction  

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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.This device was used during the same procedure as the device reported in manufacture report number 2032493-2022-00397.

Event Description

It was reported that during an embolization procedure, two (2) consecutive coils did not fit through the microcatheter.Both coils started to catch in the lumen and detached in the catheter prior to use of the controller.The coils were removed in one piece, and additional coils were used for the remainder of the procedure.There was no reported patient injury or issues.

Manufacturer Narrative

The investigation of the returned coil system found the implant separated from the pusher with coils severely stretched and monofilament broken and exposed.The pusher's heater coil showed no signs of activation using a detachment controller.Further investigation found the monofilament experienced a tensile break based on the profile of 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 returned microcatheter used in the procedure passed functional testing using an in-house coil system.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
• Type of Device: 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: 15580764
• MDR Text Key: 303562914
• Report Number: 2032493-2022-00398
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023759
• UDI-Public: (01)00816777023759(11)220117(17)261231(10)0000147917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7110-0931-A2
• Device Lot Number: 0000147917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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