MAUDE Adverse Event Report: CORDIS US CORP. MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was no sealant found in the 5f mynx control vascular closure device (vcd).The procedure was completed with manual compression.There was no reported patient injury.The missing component was noted upon deployment.The device was stored on a shelf in the manufacturer¿s box.The procedure was an interventional procedure using a retrograde approach.The user was trained in the use of the device.A 5fr cordis brite tip sheath introducer was used.The femoral artery suitability was verified, the vessel type was arterial, vessel diameter was =5 mm, there was no vessel tortuosity, and there was no peripheral vascular disease (pvd) or calcium at the puncture site.Hemostasis was achieved by manual compression for 20 minutes.There were no damages found on the device or packaging prior to opening.The device was stored and prepared according to the instructions for use (ifu).One non-sterile 5f mynx control vascular closure device (vcd) involved in the reported complaint was returned for investigation.Visual inspection revealed that button 1 and button 2 were not depressed.The stopcock was found in the open position, and no syringe was returned for this evaluation.The sealant was present in its manufactured position and was partially exposed.The catheter sheath introducer (csi) was not returned for this evaluation.The balloon was deflated, and the core wire was present, while the atraumatic tip showed no damage or abnormal condition.No additional anomalies were observed during this analysis.A dimensional analysis of the slit length could not be executed due to the split condition of the sealant sleeve assembly, which does not allow proper measurement.However, the catheter working length was verified and found to be within the specified dimensional requirement.The measurement was obtained using a calibrated ruler.An attempt was made to perform the functional test to evaluate csi insertion and withdrawal; however, the test could not be completed.Due to the split condition of the cartridge assembly, the device could not be inserted into the cannula of the previously flushed laboratory sample csi.A simulated deployment test evaluation to ensure functionality was performed.The unit worked as intended, deploying the sealant and retracting the balloon respectively.After the tension indicator was aligned by pulling the distal tip in the distal direction, button 1 and button 2 were depressed in the instructed sequence.A high-magnification microscopic evaluation was executed to evaluate the cartridge assembly.During this analysis, the presence of a split condition on the sleeves and partial exposure of the sealant were observed.The reported event of ¿sealant-missing component¿ was not observed through analysis of the returned device as the sealant was present on the unit.However, a condition was noted to the returned device of ¿mynx control system-deployment difficulty-premature¿ as a partial exposure of the sealant was observed from to the split condition of the sealant sleeves.The exact cause of the issue experienced and the observed conditions could not be determined during product evaluation.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to the missing sealant reported as the received condition did not match the event description provided.It was reported that the sealant was missing from the device and was noted upon deployment.However, the device was received with the sealant partially exposed from the split sleeves with button #1 not depressed.Therefore, it is unknown how it was determined that the sealant was missing or if the complaint device was returned for analysis.Regarding the received condition of the device, procedural/handling factors with the device and/or concomitant device factors (which was not returned for analysis) likely contributed to the frayed/split/torn 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/shredded during prepping phase and/or insertion into the sheath, that could cause the sealant to be exposed/swollen prematurely.However, as these conditions were not reported by the customer, it is unknown if this received condition occurred during the procedure or 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.¿ neither the product analysis, nor the information available for review suggests 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 or Problem Description
As reported, there was no sealant found in the 5f mynx control vascular closure device (vcd).The procedure was completed with manual compression.There was no reported patient injury.The missing component was noted upon deployment.The device was stored on a shelf in the manufacturer¿s box.The procedure was an interventional procedure using a retrograde approach.The user was trained in the use of the device.A 5fr cordis brite tip sheath introducer was used.The femoral artery suitability was verified, the vessel type was arterial, vessel diameter was =5 mm, there was no vessel tortuosity, and there was no peripheral vascular disease or calcium at the puncture site.Hemostasis was achieved by manual compression for 20 minutes.There were no damages found on the device or packaging prior to opening.The device was stored and prepared according to the instructions for use.The device was returned for evaluation.Addendum: per pe findings, the received unit presented a partially exposed sealant.

• Brand Name: MYNX CONTROL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• 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: 25182623
• Report Number: 3004939290-2026-00571
• Device Sequence Number: 10693461
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280108(10)F2600803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MX5060
• Device Lot Number: F2600803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female