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

Catalog Number MX6760E

Device Problem Premature Activation (1484)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

As reported, the tip of a 6f/7f mynx control vascular closure device (vcd) was broken as the distal end of the sealant sleeve assembly was split apart and exposing the sealant.A new unknown mynx vcd was used for hemostasis.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).The device was not used inside of the patient but was exposed to blood during handling on the scrub table after it was opened.There were no attempts to deploy the sealant prior to the malfunction occurring.The deployer was trained.The device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the tip of a 6f/7f mynx control vascular closure device (vcd) was broken as the distal end of the sealant sleeve assembly was split apart and exposing the sealant.A new unknown mynx vcd was used for hemostasis.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).The device was not used inside of the patient but was exposed to blood during handling on the scrub table after it was opened.There were no attempts to deploy the sealant prior to the malfunction occurring.The deployer was trained.A non-sterile ¿mynx control vcd 6f/7f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button 1 and button 2 were not depressed.The syringe used during the procedure was returned attached to the unit; however, the procedural sheath was not received.The stopcock was set in the closed position, and the sealant remained in its manufactured position.The sealant sleeves presented frayed conditions that resulted in the exposure of the sealant that could be related to the reported event.Dimensional analysis was not executed as the conditions of the sleeves prevented accurate measurements for verification.Per functional analysis, the deployment mechanism of the device was completed per the intended use.During this analysis, no anomaly was observed as button 1 depression resulted in the sealant¿s deployment and button 2 depression resulted in balloon retraction to complete the expected deployed mechanism.The reported events of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ and ¿mynx control system-deployment difficulty-premature¿ were confirmed through analysis of the returned device since the sealant sleeves were frayed and the sealant was exposed from the frayed sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is not possible to determine what factors may have contributed to the issue experienced.However, as the issue was reportedly found during prep of the device when the product was exposed to blood on the scrub table, prepping/handling factors are likely.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/shredded during prepping phase and/or insertion into the sheath, it could cause the sealant to be exposed/swollen prematurely.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.¿ 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, the tip of a 6f/7f mynx control vascular closure device (vcd) was broken as the distal end of the sealant sleeve assembly was split apart and exposing the sealant.A new unknown mynx vcd was used for hemostasis.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).The device was not used inside of the patient but was exposed to blood during handling on the scrub table after it was opened.There were no attempts to deploy the sealant prior to the malfunction occurring.The deployer was trained.The device will be returned for evaluation.

• 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: 19095545
• MDR Text Key: 340808655
• Report Number: 3004939290-2024-00175
• Device Sequence Number: 1
• Product Code: MGB
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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 Catalogue Number: MX6760E
• Device Lot Number: F2331802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• 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: UNKNOWN MYNX VCD
• Patient Ethnicity: Non Hispanic
• Patient Race: White