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

Catalog Number MX6760

Device Problems Premature Activation (1484); Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, a 6f/7f mynx control vascular closure device (vcd) was deployed by the doctor and it shredded according to the tech.The patient was not harmed.The product was stored and opened in a sterile field.The user was trained to the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile 6f/7f mynx control vascular closure device (vcd) involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the buttons 1 and 2 were not depressed, and the stopcock was found opened.The sealant was present as expected in its manufactured position exposed due to the damaged conditions of the sealant sleeves.The catheter sheath introducer (csi) and syringe used with the unit were not returned for this evaluation.No additional anomalies were observed during this analysis.Functional testing was executed due to the received condition of sealant premature exposure observed on the returned unit.A cordis lab syringe was attached to the unit to ensure the complete deflation of the balloon, then, after obtaining the adequate tension indication, buttons 1 and 2 were depressed.It achieved the expected mechanism by deploying the sealant and retracting the balloon successfully; showing no traces of malfunction that could be related to a compromised mechanism.The inflation/deflation mechanism could not be tested due to a longitudinal tear observed during the microscopic analysis.Per microscopic analysis, a magnified visual analysis of the sealant outer sleeves was executed.During this analysis, it was concluded that a frayed/split/torn condition was present in the sleeves portion.Additionally, a longitudinal tear was identified in the surface of the balloon body.The described conditions could be related to the reported event per the customer.The reported event of ¿mynx control system-damaged¿ was confirmed through analysis of the returned device as the sealant sleeve assembly had a condition observed as ¿sealant sleeves (cartridge assembly)-frayed/split/torn.¿ additionally, conditions were noted in the returned device of ¿balloon-balloon loss of pressure¿ due to the longitudinal tear found on the balloon, and ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the condition of the sealant sleeves noted.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 difficult to determine what factors may have contributed to the issue experienced.However, procedural/handling factors (such as using excessive force during insertion into the sheath), and/or the condition of the sheath (although not returned) possibly 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 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/shredded 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.Regarding the longitudinal tear found in the balloon, access site vessel characteristics (although not reported) and/or concomitant device factors may have contributed to the tear found on the balloon since this type of damage can occur when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent, or vascular graft).However, as this condition was not reported by the customer, it is unknown if this received condition occurred due to manipulations after the procedure.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.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture, evidence of adequate flow, no evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Neither the product 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.

Event Description

As reported, a 6/7f mynx control vascular closure device (vcd) was deployed by the doctor and it shredded according to the tech.The patient was not harmed.The product was stored and opened in a sterile field.The user was trained to the device.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: per product evaluation, during a magnified visual analysis of the sealant outer sleeves it was concluded that a frayed/split/torn condition was present in the sleeves portion, additionally a longitudinal tear was identified in the surface of the balloon body.Additionally, the sealant was present as expected in manufacturing position exposed due to the sealant sleeves damaged conditions.

• 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: 19021339
• MDR Text Key: 339135783
• Report Number: 3004939290-2024-00158
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6760
• Device Lot Number: F2327202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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
• Patient Sex: Male
• Patient Weight: 119 KG