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 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, when inserting a 5f mynx control vascular closure device (vcd) the technician encountered resistance.When they pulled the device out of the non-cordis sheath, the sealant sleeve seemed to be cracked, exposing and releasing the sealant prematurely.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The device was used in an interventional carotid procedure using an antegrade approach.The deployer was in training in the use of the mynx device.The vcd was used with a non-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 equal to 5mm in diameter.Hemostasis was achieved by manual compression for 30 minutes.The sheath was not kinked or bent upon removal.There was no visible bend or damage in distal end of the balloon shaft after removal.No excess force was applied during insertion.The sealant sleeves were not out of position.The device was removed from the package as per the ifu.The device is being returned for evaluation.

Manufacturer Narrative

As reported, when inserting a 5f mynx control vascular closure device (vcd), the technician encountered resistance.When they pulled the device out of the non-cordis sheath, the sealant sleeve seemed to be cracked, exposing and releasing the sealant prematurely.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The device was used in an interventional carotid procedure using an antegrade approach.The deployer was in training in the use of the mynx device.The vcd was used with a non-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 equal to 5mm in diameter.Hemostasis was achieved by manual compression for 30 minutes.The sheath was not kinked or bent upon removal.There was no visible bend or damage in distal end of the balloon shaft after removal.No excess force was applied during insertion.The sealant sleeves were not out of position.The device was removed from the package as per the ifu.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 was not returned for evaluation and the syringe was received connected to the device with the stopcock in the open position.In addition, the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves; and the sealant sleeves were observed to have been severely kinked/bent outward as received.The device was inspected for other damages/anomalies that may have contributed to the reported failure and no cracked conditions were observed on the returned device.A dimensional test was not performed on the returned device due to the severely kinked/bent condition observed in the sealant outer sleeve assembly.Per functional analysis, an insertion/withdrawal test could not be performed on the returned device due to the severely kinked/bent outward sealant sleeve assembly condition.The involved procedural sheath was not returned; therefore, a physical evaluation to determine whether there was damage to the procedural sheath that could have contributed to the reported complaint could not be made.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 the sealant sleeves were observed to have been severely kinked/bent outward as received.No cracked conditions were observed on the returned device.The reported event of ¿sealant sleeves (cartridge assembly)-cracked¿ was not confirmed through analysis of the returned device since there were no cracks observed; however, a severely kinked condition of the sleeves was noted.Also, the reported event of ¿mynx control system-impeded¿ was confirmed since the device could not be inserted during the insertion/withdrawal test due to the kinked/bent sleeves, and the reported event of ¿mynx control system-deployment difficulty-premature¿ was confirmed 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 (although it was reported that excessive force was not applied), and/or the condition of the sheath (although not returned and reported to not have a kinked/bent condition noted after removal) 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.

• 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: 18781939
• MDR Text Key: 336426481
• Report Number: 3004939290-2024-00084
• 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,Followup
• Report Date: 04/30/2024

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: F2330503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: TERUMO SHEATH