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

Catalog Number MX5060E

Device Problem Decrease in Pressure (1490)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

As reported, during the 5f mynx control device preparation, sterile heparinized saline leaked from the balloon.The balloon ruptured.There was no reported injury to the patient.The deployer was certified in using mynx.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The device storage temperature did not exceed 25 °c.There were no anomalies noted prior to use.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The stopcock was locked after inflation.There was no presence of pvd/calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The device will be returned for analysis.

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.

Manufacturer Narrative

As reported, during the 5f mynx control device preparation, sterile heparinized saline leaked from the balloon.The balloon ruptured.There was no reported injury to the patient.The deployer was certified in using mynx.The device was prepared and stored according to the instructions for use (ifu), and no damage was observed prior to opening the package.The device storage temperature did not exceed 25 °c.There were no anomalies noted prior to use.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The stopcock was locked after inflation.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.There was no scar tissue present 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 syringe was received connected to the device with the stopcock observed opened, and the procedural sheath was not received for evaluation.The balloon was found fully deflated.The sealant was not exposed to blood and was found partially exposed from the sealant sleeves, which were observed to have been kinked/bent as received.Per functional analysis, an inflation/deflation test was performed per the mynx control ifu.The results revealed a leak in the balloon of the returned device.A simulated deployment test was performed with 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.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 revealed a longitudinal tear in the balloon of the return device.In addition, the sealant was found not exposed to blood and was partially exposed from the sealant sleeves, which were observed to have been kinked/bent as received.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the kinked/bent condition of the sealant sleeves noted.However, the exact cause of the longitudinal tear found in the balloon and the condition of the exposed sealant 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 issues noted.However, prepping/handling factors are possible as the balloon loss of pressure event was noted during preparation of the device by the customer.Additionally, these factors could also contribute to the kinked/bent 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 is assembled with 2 side slit overlapping outer sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.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 the sheath, that could cause the sealant to be exposed/swollen prematurely.However, as this condition was not reported by the customer, it is unknown if this received condition occurred due to manipulations after the procedure.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu states, ¿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, ¿prepare balloon: fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Deflate the balloon and leave syringe at neutral.Do not lock.¿ neither the product analysis, nor the information available for review suggest that the failures noted 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, during the 5f mynx control device preparation, sterile heparinized saline leaked from the balloon.The balloon ruptured.There was no reported injury to the patient.The deployer was certified in using mynx.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The device storage temperature did not exceed 25 °c.There were no anomalies noted prior to use.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The stopcock was locked after inflation.There was no presence of pvd / calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The device will be returned for analysis.

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, during the 5f mynx control device preparation, sterile heparinized saline leaked from the balloon.The balloon ruptured.There was no reported injury to the patient.The deployer was certified in using mynx.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The device storage temperature did not exceed 25 °c.There were no anomalies noted prior to use.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The stopcock was locked after inflation.There was no presence of pvd / calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The device will be returned for analysis.

• 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, california 95054 ; 7863138372
• MDR Report Key: 17886732
• MDR Text Key: 325260894
• Report Number: 3004939290-2023-03407
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044 MGB
• 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,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX5060E
• Device Lot Number: F2313703
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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: N/A.