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

Catalog Number MX6760

Device Problem Premature Activation (1484)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the distal tip of the sealant sleeves of a 6f/7f mynx control vascular closure device (vcd) split and peeled back upon insertion of the distal tip of the cannula, causing as frayed/split/torn condition.The sealant sleeves were frayed/split/torn after attempting insertion into the 6f cordis avanti sheath.The device was not delivered intra-arterially.Hemostasis was achieved by another mynx device.There was no reported patient injury.The product was stored per labeling and opened in a sterile field.The device was inspected prior to use and no damages were noted.The femoral artery¿s suitability verified on angiography, including the insertion angle (30-45 degrees) of the 6f 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.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx contr0ol vcd, 6f/7f¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected, observing that both button 1 and button 2 were not depressed.The syringe and the sheath were not returned for analysis.The stopcock was set on the closed position.The sealant remained in its manufactured position, swelled by the blood saturation and prematurely exposed.The atraumatic tip did not present any damages or anomalies.The sealant sleeves presented a kinked condition.No other outstanding details were noticed.Per microscopic analysis, the kink was inspected using a vision system to obtain a magnified image.In addition, it could also be observed that the sealant was prematurely exposed.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a kinked condition of the sleeves was noted.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked sleeves.The exact cause of the observed condition 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 issue experienced.However, procedural/handling factors (such as excessive force during insertion and/or incorrect insertion angle), and/or the condition of the sheath (although not returned) possibly contributed to the damaged condition of the sealant sleeves, and the subsequent premature exposure of the sealant.It should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing.The outer sleeve assembly is assembled with 2 side slit overlapping outer sleeves.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.If the outer sleeve is damaged/kinked during prepping phase and/or insertion into sheath, it could cause the sealant to be exposed/swollen prematurely and/or obstruct the device path and prevent the device from being inserted into the procedural sheath.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.¿ neither the product analysis, nor the information available for review suggest that the failures could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Event Description

As reported, the distal tip of the sealant sleeves of a 6/7f mynx control vascular closure device (vcd) split and peeled back upon insertion of the distal tip of the cannula causing as frayed/split/torn condition.The sealant sleeves were frayed/split/torn after attempted insertion into the 6f cordis avanti sheath.The device was not delivered intra-arterially.Hemostasis was achieved by another mynx device.There was no reported patient injury.The product was stored per labeling and opened in a sterile field.The device was inspected prior to use and no damages were noted.The femoral artery¿s suitability verified on angiography or venography, including the insertion angle (30-45 degrees) of the 6f 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.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product evaluation revealed the sealant remained in the manufacturing position swelled by the blood saturation and prematurely exposed.

• 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: 18324794
• MDR Text Key: 330951292
• Report Number: 3004939290-2023-03532
• 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
• Report Date: 12/14/2023

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: MX6760
• Device Lot Number: F2317903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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.; ANOTHER MYNX DEVICE.
• Patient Sex: Female