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)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.There were no reports of patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The mynx vcd was used in a diagnostic procedure.A retrograde approach was used.The deployer was mynx certified.A 5f non-cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 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 pvd / calcium in the vicinity of the puncture site.Hemostasis was achieved in less than 30 minutes via manual compression.The balloon lost pressure while inside of patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The device will be returned for further analysis and 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 of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.There were no reports of patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The mynx vcd was used in a diagnostic procedure.A retrograde approach was used.The deployer was mynx certified.A 5f non-cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.Hemostasis was achieved in less than 30 minutes via manual compression.The balloon lost pressure while inside of patient.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button #1 and button #2 were not depressed.Neither the syringe, nor the procedural sheath were returned for analysis.The sealant was blood-saturated and remained in its manufactured position fully covered by the sleeves.The balloon was not inflated, and the inside was saturated with saline solution.The atraumatic tip did not present any damages or anomalies.No other outstanding details were noticed.Per functional analysis, an inflation/deflation test was performed by injecting water into the returned device according to the ifu.However, due to the saturation of dried saline solution inside the balloon, the inflation process was not successful.The unit was submerged into an ultrasonic machine; however, due to the high concentration, it was not possible to remove the saline solution.Per microscopic analysis, the balloon was inspected using a vision system to obtain a magnified image, and the dense saline solution saturation was confirmed with no damages noted.The reported event of ¿balloon-balloon loss of pressure¿ was not confirmed through analysis of the returned device since inflation test could not be performed due to the clogged inflation lumen and no damage was observed to the balloon during microscopic analysis.The exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the reported event since there were no damages noted to the balloon.However, handling factors, such as excessive force during pullback, are possible.Although not intended as a mitigation, the mynx control instructions for use (ifu) states to ¿grasp the device handle and align the device with the tissue tract.Pull gently to retract the device until the black line in the tension indicator window aligns with the markers on the side, indicating the balloon is abutting the arteriotomy with the correct amount of tension.¿ additionally, the ifu instructs users to discard the device if the balloon does not maintain pressure.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 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: 18918612
• MDR Text Key: 337847365
• Report Number: 3004939290-2024-00119
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: F2329201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2023
• 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