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

Catalog Number MX5060

Device Problem Premature Activation (1484)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the sealant of a 5f mynx control vascular closure device (vcd) was deployed outside of the patient while attempting to insert into the 5f non-cordis sheath.It was exposed to bodily fluids with no damage to the sealant sleeves that resulted in the sealant exposure.A new unknown mynx was opened, and closure was achieved.There was no reported patient injury.The device was removed from the package per the instructions for use (ifu).There were no damages noted to the sealant sleeves (cartridge assembly), and they were not out of position.There was exposure of the sealant to bodily fluids and it was not due to any damage to the sealant sleeves.The femoral artery¿s suitability was verified on angiography, 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 no vessel tortuosity.The mynx vcd was used in an interventional procedure with an antegrade approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was discarded; therefore, it will not be returned for evaluation.The reported event of ¿mynx control system-deployment difficulty-premature¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, it is not possible to determine what factors may have contributed to the reported premature exposure of the sealant since it was also reported that there were no visible signs of damage to the sealant sleeves.However, as it was reported that the sealant was exposed to bodily fluids, procedural/handling factors possibly contributed to the premature swelling of the sealant, and the subsequent premature exposure.It should be noted that the mynx control device is manufactured with the sealant sleeve assembly at the distal end of the catheter cartridge tubing.The sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the sealant sleeve assembly and is protected from being exposed prematurely.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.As warned in the ifu, which is not intended as a mitigation, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ additionally, the ifu states ¿step 1: position balloon, insert the mynx control vcd into the procedural sheath through the sheath valve.Advance the catheter until the sheath catch nears the hub of the sheath.Rotate the sheath catch as needed to hook onto the side port of the procedural sheath.¿ based on the information available for review, there is no indication that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the sealant of a 5f mynx control vascular closure device (vcd) was deployed outside of the patient while attempting to insert into the 5f non-cordis sheath.It was exposed to bodily fluids with no damage to the sealant sleeves that resulted in the sealant exposure.A new unknown mynx was opened, and closure was achieved.There was no reported patient injury.The device was removed from the package per the instructions for use (ifu).There was no damages noted to the sealant sleeves (cartridge assembly).The sealant sleeves (cartridge assembly) were not out of position.There was exposure of the sealant to bodily fluids and it was not due to any damage to the sealant sleeves.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 no vessel tortuosity.The mynx vcd was used in interventional procedure with an antegrade approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was discarded; therefore it will not be returned for evaluation.

• 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: 18831731
• MDR Text Key: 337785544
• Report Number: 3004939290-2024-00099
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: 20862028000424
• 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
• Report Date: 03/04/2024

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: F2325001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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; ANOTHER UNKNOWN MYNX
• Patient Sex: Female
• Patient Weight: 65 KG