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

Catalog Number MX5060E

Device Problem Premature Activation (1484)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the outer sleeve of a 5f mynx control vascular closure device (vcd) struck the edge of the 5f non-cordis sheath hub causing it to split while the user attempted to advance the device through the 5f non-cordis sheath.As a result, it became difficult to fully insert the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).The device was inspected prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 5f vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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 with the stopcock opened.The syringe was not connected to the device¿s luer hub.The procedural sheath was not returned for analysis.The sealant remained in its manufacturing position, swollen/saturated by blood and exposed.The sealant exposure was due to a severe outward kinked condition noted to the sealant sleeves.No damages, or anomalies were observed to the atraumatic wire.No other outstanding details were noticed.Per dimensional analysis, the catheter working length was measured to be verified, and the result was found within specification.However, the slit length on the outer sleeve was not verified due to the severe outward kinked condition of the sealant sleeve assembly noted.Per microscopic analysis, the sealant area was inspected with a vision system to obtain a magnified image, and it was observed that the sealant sleeve assembly presented an outward kinked condition, which exposed the sealant.The sealant remained in its manufactured position, swelled and saturated in blood.No other outstanding details were noticed.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severe outward 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 conditions 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 using excessive force during insertion into the sheath and/or using an incorrect insertion angle), and/or the condition of the sheath (although not returned) possibly contributed to the damaged condition of the sealant sleeves, the impedance experienced during insertion, 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 outer sleeve of a 5f mynx control vascular closure device (vcd) struck the edge of the 5f non-cordis sheath hub causing it to split while the user attempted to advance the device through the 5f non-cordis sheath.As a result, it became difficult to fully insert the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).The device was inspected prior to use.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 5f vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in a diagnostic procedure with a retrograde approach.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: per product evaluation, the sealant of a 5f mynx control remained in the manufacturing position swollen, saturated by blood, and exposed due to the sleeves presenting a severe outward kinked condition.

• 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: 19214983
• MDR Text Key: 341820290
• Report Number: 3004939290-2024-00216
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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: F2322001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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 DEVICE