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

Catalog Number MX6760

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

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

Event Date 02/20/2024

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 6/7f mynx control vascular closure device (vcd) ruptured during deployment.Hemostasis was achieved by manual compression for 15 minutes.There was no reported patient injury.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The device was used with a 6f 12cm non-cordis sheath.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 no vessel tortuosity.There was no presence of pvd / calcium in the vicinity of the puncture site.The device was stored and prepped per the instructions for use (ifu).The balloon lost pressure while inside of the patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The balloon lost pressure after being pulled to the arteriotomy.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 a 6f/7f mynx control vascular closure device (vcd) ruptured during deployment.Hemostasis was achieved by manual compression for 15 minutes.There was no reported patient injury.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The device was used with a 6f 12cm non-cordis sheath.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 no vessel tortuosity.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The device was stored and prepped per the instructions for use (ifu).The balloon lost pressure while inside of the patient.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.The balloon lost pressure after being pulled to the arteriotomy.A non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe was received connected to the device with the stopcock observed closed; and the balloon was found fully deflated.Furthermore, a cordis procedural sheath was locked on to the device with blood noted in it.There were no damages observed to the procedural sheath.In addition, the sealant was found in its manufactured position, fully covered by the sealant sleeves and not exposed to blood.In addition, no damages were observed to sealant sleeves assembly.Per functional analysis, an inflation/deflation test was performed per the mynx control ifu.The results revealed a leak in the balloon of the returned device.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is difficult to determine what factors may have contributed to the loss of pressure reported.However, access site vessel characteristics (although reported that there was no presence of pvd/calcium in the vicinity of the puncture site) and/or handling factors most likely contributed to the reported event since a calcified vessel, concomitant device factors (such as a stent, or vascular graft), and/or handling factors 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 device preparation states 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 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: 18919106
• MDR Text Key: 337855793
• Report Number: 3004939290-2024-00121
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: MX6760
• Device Lot Number: F2207504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2022
• 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: ABBOTT .038 12CM 6F SHEATH.
• Patient Age: 56 YR
• Patient Sex: Female