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

Catalog Number MX5060E

Device Problems Decrease in Pressure (1490); Material Rupture (1546); Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

As reported, the balloon on a 5f mynx control vascular closure device (vcd) "came out" without getting caught inside vessel wall after the user attempted to deploy the device by pressing button 1.Hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.There were no reports of patient injury.There is no trace of balloon rupture.It was reported that the balloon came out while being pressed into an oval shape.The device was purged of air during prep.There was no scar tissue present in the vicinity of the puncture site.Manual compression was performed.There was no excessive tension applied to the device.The user applied right tension as indicated in the tension indicator.There were no multiple sheath exchanges prior to the use of the mynx device.The device was used during coronary angiogram procedure and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use (ifu).The vessel type was the femoral artery, and its diameter was verified to be greater than 5 mm.The mynx vcd was prepped according to the instructions for use (ifu).The device will be 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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon on a 5f mynx control vascular closure device (vcd) "came out" without getting caught inside vessel wall after the user attempted to deploy the device by pressing button 1.Hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.There were no reports of patient injury.There is no trace of balloon rupture.It was reported that the balloon came out while being pressed into an oval shape.The device was purged of air during prep.There was no scar tissue present in the vicinity of the puncture site.Manual compression was performed.There was no excessive tension applied to the device.The user applied the correct amount of tension as indicated in the tension indicator.There were no multiple sheath exchanges prior to the use of the mynx device.The device was used during coronary angiogram procedure and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use (ifu).The vessel type was the femoral artery, and its diameter was verified to be greater than 5 mm.The mynx vcd was prepped according to the instructions for use (ifu).The device will be returned for evaluation.A non-sterile mynx control vascular closure device 5f, the syringe involved in the reported complaint and the cordis csi related to the complaint were returned for analysis.Visual inspection of the received device showed both button 1 and button 2 were fully depressed.The stopcock was found open.The sealant was not present in the device.The device showed exposure to blood.The balloon was fully retracted, as expected since button 2 was fully depressed.No other anomalies were observed during the analysis.A balloon retraction functional test was performed.The balloon was manually exposed to simulate the retraction by completely depressing button 2.The balloon successfully retracted after button 2 was fully depressed.A go / no-go functional test could not be completed because the balloon was unable to maintain the pressure after it was inflated.Inspection under a vision system confirmed a puncture to the balloon while it was being inflated.The reported, ¿balloon - pull through¿ could not be confirmed due to the nature of the complaint.However, the ruptured balloon is a possible underlying cause.The malfunction, ¿balloon-loss of pressure¿ was confirmed.The exact cause of the reported event could not be conclusively determined.This type of tear is typically observed when the balloon encounters calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft).According to the instructions for use, which is not intended as a mitigation of risk, users are instructed not to use the device if the balloon does not maintain pressure.Based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara, california 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, california 95054 ; 7863138372
• MDR Report Key: 18284638
• MDR Text Key: 330818982
• Report Number: 3004939290-2023-03521
• 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: 02/21/2024

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: F2325401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian