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

Catalog Number MX5060

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

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

Event Date 01/18/2024

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 when inflated in the vessel and was removed.Manual pressure was held for hemostasis there was no reported patient injury.The vcd was used for closure of a procedure.The device was used during a left leg popliteal atherectomy, using a retrograde approach.The deployer was certified in the use of the mynx device.The device was used with a 6f 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 or calcium in the vicinity of the puncture site.The device was stored and prepped per the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery.The balloon lost pressure after being pulled to the arteriotomy.The device is being returned for evaluation.

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) ruptured when inflated in the vessel and was removed.Manual pressure was held for hemostasis there was no reported patient injury.The vcd was used for closure of a procedure.The device was used during a left leg popliteal atherectomy, using a retrograde approach.The deployer was certified in the use of the mynx device.The device was used with a 6f 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 or calcium in the vicinity of the puncture site.The device was stored and prepped per the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery.The balloon lost pressure after being pulled to the arteriotomy.The device was returned however not received for evaluation.

Manufacturer Narrative

As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) ruptured when inflated in the vessel and was removed.Manual pressure was held for hemostasis there was no reported patient injury.The vcd was used for closure of a procedure.The device was used during a left leg popliteal atherectomy, using a retrograde approach.The deployer was certified in the use of the mynx device.The device was used with a 6f 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) or calcium in the vicinity of the puncture site.The device was stored and prepped per the instructions for use (ifu).There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The balloon lost pressure after being pulled to the arteriotomy.The device was returned however not received for evaluation.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not received for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, it is difficult to determine what factors may have contributed to the loss of pressure reported.However, access site vessel characteristics (balloon lost pressure after being pulled to the arteriotomy although reported that there was no presence of pvd/calcium at the vicinity of the puncture site) and/or concomitant device factors are likely since calcification at the access site and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon, resulting in a loss of pressure.According to the mynx control 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 prior to using the mynx control vcd: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Based on the information available for review, there is no indication that the event is related to the design or manufacturing process of the unit.Therefore, no corrective/preventative action 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: 18684132
• MDR Text Key: 335091871
• Report Number: 3004939290-2024-00067
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: MX5060
• Device Lot Number: F2329703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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: 6F CORDIS AVANTI SHEATH