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 10/04/2023

Event Type  malfunction  

Event Description

As reported, button 1 of a 6/7f mynx control vascular closure device (vcd) was not able to be pushed down.There was no reported patient injury.The device was used in an interventional procedure.The deployer was certified 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 greater than or equal to 5mm in diameter.Hemostasis was achieved by manual compression for 30 minutes.There was no damage noted to the button, which could no be pushed.The device storage temperature did not exceed 25 degrees celsius.The device will be returned for evaluation.Addendum: product analysis demonstrates that the sealant was found exposed from the sealant sleeves.

Manufacturer Narrative

As reported, button 1 of a 6/7f mynx control vascular closure device (vcd) was not able to be pushed down.There was no reported patient injury.The device was used in an interventional procedure.The deployer was certified 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 greater than or equal to 5mm in diameter.Hemostasis was achieved by manual compression for 30 minutes.There was no damage noted to the button, which could not be pushed.The device storage temperature did not exceed 25 degrees celsius.A non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation inside a clear plastic bag.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe was received connected to the device, in addition, an unknown procedure sheath was locked on to the sheath catch and blood was noted in the procedure sheath.The stopcock was found open.The sealant was found exposed from the sealant sleeves and it was observed to have been kinked/bent as received.Additionally, the sealant was found swollen due to exposure to blood.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control instructions for use (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.The returned device performed as intended per the mynx control ifu.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found exposed from the sealant sleeves due to this, it was observed to have been kinked/bent as received.The reported event of ¿button #1-frozen/locked¿ was not confirmed through analysis of the returned device as it passed functional analysis.However, noted upon device return ¿mynx control system-deployment difficulty-premature¿ was observed as the sealant was found exposed from the sealant sleeves, the sleeves were noted to be kinked/bent, and the sealant was found swollen due to exposure to blood.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 unclear why there was a reported difficulty with pressing button #1 as it passed functional analysis with no difficulties.Nevertheless, procedural and/or handling factors may have contributed to the kinked/bent condition of the sealant sleeves, and the subsequent premature exposure of the sealant.Additionally, it should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.If the outer sleeve is damaged/shredded during prepping phase and/or insertion into sheath, that 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.¿ according to the instructions for use, ¿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.Grasp the device handle and align the device with the tissue tract.Pull gently to retract the device until the black line in the tension indicator window aligns with the markers on the side, indicating the balloon is abutting the arteriotomy with the correct amount of tension.While maintaining tension press button #1 until it is fully aligned with the handle, and the clock symbol is visible in the tension indicator window.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture, evidence of adequate flow, no evidence of significant pvd in the vicinity of the puncture.¿ the product analysis does not suggest that the issues experienced could be related to the design or manufacturing process of the unit.Therefore, no corrective or 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
• 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: 18265625
• MDR Text Key: 329718042
• Report Number: 3004939290-2023-03516
• 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: 12/05/2023

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: F2313102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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: TERUMO SHEATH
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White