MAUDE Adverse Event Report: CORDIS US CORP. MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number MX5060E

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) burst during the ballooning process.There was no reported patient injury.The device was used in a transcatheter arterial chemoembolization (tace) treatment.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: h6 this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Clarification of lot and product number pending.Once received, will update accordingly.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6 as reported, the balloon of a 5f mynx control vascular closure device (vcd) burst during the ballooning process.There was no reported patient injury.The device was used in a transcatheter arterial chemoembolization (tace) treatment.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that both button 1 and button 2 were not depressed.The syringe was received connected to the device and the procedural sheath was not received for evaluation.The stopcock was observed opened.The sealant was found in its manufactured position, fully covered by the sealant sleeves, and not exposed to blood.The balloon was found fully deflated.Per functional analysis, an inflation/deflation test was performed on the balloon of the returned device, and during this evaluation, the balloon was fully inflated with pressure maintained.The balloon was able to be inflated/deflated with proper functioning of the inflation indicator as intended per the mynx control instructions for use (ifu).Per microscopic analysis, visual inspection at high magnification showed that the balloon of the returned device maintained pressure and could be fully deflated.The reported event of ¿balloon-balloon loss of pressure¿ was not confirmed through analysis of the returned device since the balloon passed functional analysis.The exact cause of the reported incident could not be conclusively determined during analysis of the returned device.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced since there was no rupture noted.However, balloon prep and/or handling factors are possible.Although not intended as a mitigation, the mynx control ifu instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.It also states to check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Failure to purge the device of air during the prep phase and/or excessive tension applied to the catheter during pullback can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and cause the balloon to be pulled through the arteriotomy, which can be mistaken as a balloon rupture.Neither the product analysis, nor the information available for review suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 18913870
• MDR Text Key: 337779471
• Report Number: 3004939290-2024-00113
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MX5060E
• Device Lot Number: F2320006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/07/2024; 04/29/2024
• Supplement Dates FDA Received: 04/07/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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
• Treatment: UNKNOWN.
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian