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 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the outer sleeve of a 5f mynx control vascular closure device (vcd) struck the edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Hemostasis was achieved with another unknown mynx device.There were no reports of patient injury.This occurred while the user attempted to advance the mynx control vcd through the sheath.The device was stored and prepared according to the instructions for use (ifu).The mynx vcd was used in a diagnostic procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 5f non-cordis sheath was used.The femoral artery 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 little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that both button 1 and button 2 were not depressed.The procedural sheath and the syringe were not returned for evaluation, and the stopcock was observed closed.In addition, the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves and exposed to blood.Additionally, the sealant sleeves were observed to have been severely kinked/bent.The device was inspected for damages/anomalies that may have contributed to the reported failure, and no frayed/split/torn conditions were observed on the returned device.A dimensional test was not performed on the returned device due to the kinked/bent condition observed in the sealant outer sleeve assembly.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control ifu, step 2: deploy sealant.Button 1 was able to be depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1 deployment during the device failure investigation.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.The returned device performed as intended per the mynx control ifu.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found exposed from the sealant sleeves and exposed to blood.The sealant sleeves were observed to have been severely kinked/bent; however, no frayed/split/torn conditions were observed on the device.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked/bent 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 edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Hemostasis was achieved with another unknown mynx device.There were no reports of patient injury.This occurred while the user attempted to advance the mynx control vcd through the sheath.The device was stored and prepared according to the instructions for use (ifu).The mynx vcd was used in a diagnostic procedure.The procedure used a retrograde approach.The deployer was mynx certified.A 5f non-cordis sheath was used.The femoral artery 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 little vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.The device will be returned for evaluation.Addendum: per product analysis, the sealant was found exposed from the sealant sleeves and exposed to blood.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara, california 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, california 95054 ; 7863138372
• MDR Report Key: 19186203
• MDR Text Key: 341126433
• Report Number: 3004939290-2024-00206
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• 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: F2329609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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: UNKNOWN SHEATH