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

Catalog Number MX5021

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

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 5f mynxgrip vascular closure device (vcd) failed to inflate properly during the prepping stage.Hemostasis was achieved by another mynx device.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The balloon was prepped with 50/50 contrast.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was little vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: the balloon of a 5f mynxgrip was observed with a longitudinal tear present in the balloon¿s surface.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynxgrip vascular closure device (vcd) failed to inflate properly during the prepping stage.Hemostasis was achieved by another mynx device.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The balloon was prepped with 50/50 contrast/saline.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was little vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile 5f 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 used 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 activated when the device was handled by the user, and this condition does not match the description provided.A microscopic analysis was performed to the balloon to confirm the state of the surface and body.During the analysis, a longitudinal tear was observed to be present in the balloon¿s surface.This tear was concluded to be attributable to the balloon inflation difficulty reported.Functional testing was executed using the returned syringe and a cordis lab syringe, and the balloon could not be inflated due to the longitudinal rupture that was perceived during the microscopic test.The reported event of ¿balloon-inflation difficulty¿ was confirmed through analysis of the returned devices due to the leak found in the balloon that prevented inflation.Therefore, the additional condition of ¿balloon-balloon loss of pressure at prep¿ was found due to the leak.However, the exact cause of the longitudinal tear found in the balloon could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, prepping/handling factors (such as an interaction with a sharp-edged material) may have contributed to tear noted and the subsequent inflation difficulty reported.However, as the device was received with the sealant and advancer tube fully deployed, it is possible that access site vessel characteristics and/or concomitant device factors (although not returned) could have contributed to the tear found if the device was used in the procedure.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu states, ¿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.¿ additionally, the device preparation states, "inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and the syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.¿ 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: 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: 18760241
• MDR Text Key: 336979647
• Report Number: 3004939290-2024-00081
• 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
• Report Date: 03/19/2024

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: MX5021
• Device Lot Number: F2318605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• 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: 5F TERUMO SHEATH.; UNKNOWN MYNX DEVICE.