MAUDE Adverse Event Report: CORDIS 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 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, when using a 5f mynx control vascular closure device (vcd), the user attempted to deploy the mynx sealant by pressing button 1 but was unable to do so due to a faulty button.The button did not have any visible damage and could not be depressed at all.No patient injuries were reported, and hemostasis was achieved by manual compression for twenty-five (25) minutes, resulting in no extended hospitalization.The device was used during a transfemoral cerebral angiography using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use (ifu).The vessel type was the femoral arterial, and its diameter was verified to be greater than 5 mm.The mynx vcd was prepared according to the ifu.The device storage temperature did not exceed 25 °c.There were no visible signs of device/package damage prior to use.The puncture site did not have visible calcium/plaque or vessel tortuosity nor a stent near the puncture site.There was no vessel stenosis of greater than fifty percent (50%) at or near the puncture site.The tension indicator was aligned with the markers on the handle halves before attempting to deploy the device.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed with the stopcock opened, the syringe was received connected to the device, the sealant was found partially exposed from the sealant sleeves assembly, which were observed to have been slightly kinked/bent as received.In addition, the procedural sheath was not received for evaluation and the balloon was observed fully deflated.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.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 partially exposed from the sealant sleeves assembly due to the slightly kinked/bent condition observed as received.The reported event of ¿button #1-frozen/locked¿ was not confirmed through analysis of the returned device since it passed functional analysis.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ as a partial exposure of the sealant was observed due to the slightly kinked/bent condition of the sealant sleeves noted.However, the exact cause of the issue experienced by the customer and the premature exposure of the 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 frozen/locked button 1 experienced since it passed functional analysis.However, handling factors (physician was being trained on its use) are possible.Additionally, procedural/handling factors possibly resulted in the kinked/bent condition of the sealant sleeves (such as excessive force 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 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.However, as this condition was not reported by the customer, it is unknown if this condition occurred during use in 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.According to the mynx control ifu, ¿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.¿ the ifu also warns, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ neither the product analysis, nor the information available for review suggest that the issues experienced 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, when using a 5f mynx control vascular closure device (vcd, the user attempted to deploy the mynx sealant by pressing button1 but was unable to do so due to a faulty button.The button did not have any visible damage and could not be depressed at all.No patient injuries were reported, and hemostasis was achieved by manual compression for twenty-five (25) minutes, resulting in no extended hospitalization.The device was used during a transfemoral cerebral angiography using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use (ifu).The vessel type was the femoral arterial, and its diameter was verified to be greater than 5 mm.The mynx vcd was prepared according to the ifu.The device storage temperature did not exceed 25 °c.There were no visible signs of device/package damage prior to use.The puncture site did not have visible calcium/plaque or vessel tortuosity nor a stent near the puncture site.There was no vessel stenosis of greater than fifty percent (50%) at or near the puncture site.The tension indicator was aligned with the markers on the handle halves before attempting to deploy the device.The device was received for evaluation.Visual inspection of the device at high magnification found the sealant was partially exposed from the sealant sleeves assembly.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer (Section G): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 18483622
• MDR Text Key: 332551987
• Report Number: 3004939290-2024-00015
• 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: 01/10/2024

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: MX5060E
• Device Lot Number: F2306703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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: NO INFORMATION.
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian