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

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

This device is reported to not be available for analysis and no device has been received at the time of this report.An image has been received but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sealant protection plastic of a 5f mynx control vascular closure device (vcd) was bent out of place when the customer opened it.The user did not attempt to use these on the patient.There was no reported patient injury.There was no damage observed to the packaging.There was no difficulty removing the device from the packaging.The device was not manipulated in any way prior to noticing the damage.The device will be returned for analysis.Addendum: preliminary review of the image received demonstrates that one of the sealant sleeves was bent outward, exposing the sealant.

Manufacturer Narrative

Complaint conclusion: as reported, the sealant protection plastic of a 5f mynx control vascular closure device (vcd) was bent out of place when the customer opened it.The user did not attempt to use these on the patient.There was no reported patient injury.There was no damage observed to the packaging.There was no difficulty removing the device from the packaging.The device was not manipulated in any way prior to noticing the damage.The device was not returned for analysis because it was discarded.However, one photo was received for review.Per the picture analysis, the distal section of a mynx control was noted.The sealant sleeve was found split, and the sealant was found exposed from that side.No other outstanding anomalies were noted from the picture.The reported event of ¿sealant sleeves (cartridge assembly)-kinked/bent¿ was not confirmed through analysis of the received picture since there was no kinked/bent damage noted; however, a split condition of the sleeves was noted.Additionally, a condition was noted in the received picture of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the split sleeves.The exact cause of the observed conditions could not be conclusively determined during picture analysis.Based on the limited information available for review and picture analysis, it is difficult to determine what factors may have contributed to the issue experienced.However, prepping/handling factors possibly contributed to the damaged 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 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 picture 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: 19135546
• MDR Text Key: 340514270
• Report Number: 3004939290-2024-00196
• 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
• Report Date: 04/18/2024

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 Model Number: N/A
• Device Catalogue Number: MX5060
• Device Lot Number: F2402901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2024
• 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