MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number MX6721

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

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

As reported, the balloon of two 6/7f mynxgrip vascular closure devices (vcd) burst before deployment of the closure material.Another third device was used successfully for closure.There was no reported patient injury.The device is being returned for evaluation.

Manufacturer Narrative

This report is related to medwatch# 3004939290-2023-03549 additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of two 6/7f mynxgrip vascular closure devices (vcd) burst before deployment of the closure material.Another third device was used successfully for closure.There was no reported patient injury.Additional information was requested but not provided.The device is being returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the balloon of two 6f/7f mynxgrip vascular closure devices (vcd) burst before deployment of the closure material.Another third device was used successfully for closure.There was no reported patient injury.Additional information was requested but not provided.A non-sterile 6f/7f mynxgrip vascular closure device involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle.The sheath used in the procedure was not returned with the device for the evaluation; nevertheless, the syringe was observed attached to the returned unit with the stopcock opened.The sealant and advancer tube were not returned; therefore, the conditions observed led the investigator to infer that the deployment mechanism was possibly completed during the procedure when the device was used.Functional testing was executed using the returned syringe and the cordis lab syringe, and the balloon could not be inflated as a longitudinal rupture could be perceived during the microscopical test.A microscopic analysis was performed in the balloon to confirm the state of the surface and body.During the analysis, it was observed that a longitudinal tear was present in the balloon¿s surface.This tear was concluded to be attributable to the balloon loss of pressure reported.The reported events of ¿balloon-balloon loss of pressure¿ were confirmed through analysis of the returned devices.However, the exact cause of the longitudinal tears found could not be conclusively determined during analysis.Based on the limited information available for review and product analyses, it is not possible to determine what factors may have contributed to the loss of pressures reported.However, access site vessel characteristics (although not reported) and/or concomitant device factors (which were not returned) most likely contributed to the reported events since a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause this type of damage to the balloon.According to the instructions for use (ifu), which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu states to discard the device if the balloon does not maintain pressure.Neither the product analyses, nor the information available for review suggest that the reported failures could be related to the design or manufacturing process of the units.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: MYNXGRIP
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• 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: 18376994
• MDR Text Key: 331137007
• Report Number: 3004939290-2023-03550
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

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: MX6721
• Device Lot Number: F2229902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/23/2024; 03/05/2024
• Supplement Dates FDA Received: 02/19/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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
• Treatment: UNKNOWN DEVICE