MAUDE Adverse Event Report: CARDINAL HEALTH 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 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

E1- reporter address information remains unknown.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, while using a 5f mynx control vascular closure device (vcd) button 1 was not able to "release" and there were difficulties accessing the distal tip into the sheath.There was resistance with the button and it was not able to be depressed.Hemostasis was achieved by manual compression.There was no reported patient injury.A second healthcare provider described the difficulties inserting the distal tip into the sheath as issues with technique of insertion.The second healthcare provider succeeded in insertion on their first attempt.The lot information will remain unknown as the package was destroyed.The device was stored and prepped according to the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The user is trained on use of the mynx control device.No excess force was applied during insertion.The sheath was not kinked/bent upon removal.There was no damage noted to the button.The button depressed halfway.The tension indicator was aligned with the markers on the handle halves before attempting to deploy.The device storage temperature did not exceed 25 degrees celsius.There were no damages noted to the sealant sleeves after removal.The device is being returned for evaluation.Addendum: on product evaluation, the sealant was found exposed from the sealant sleeves.

Manufacturer Narrative

As reported, while using a 5f mynx control vascular closure device (vcd) button 1 was not able to "release" and there were difficulties inserting the distal tip into the sheath.There was resistance with the button and it was not able to be depressed.Hemostasis was achieved by manual compression.There was no reported patient injury.A second healthcare provider described the difficulties inserting the distal tip into the sheath as issues with technique of insertion.The second healthcare provider succeeded in insertion on their first attempt.The lot information will remain unknown as the package was destroyed.The device was stored and prepped according to the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The user is trained on use of the mynx control device.No excess force was applied during insertion.The sheath was not kinked/bent upon removal.There was no damage noted to the button.The button depressed halfway.The tension indicator was aligned with the markers on the handle halves before attempting to deploy.The device storage temperature did not exceed 25 degrees celsius.There were no damages noted to the sealant sleeves after removal.A non-sterile ¿mynx control vcd 5f¿ was returned for evaluation.Visual inspection of the received device showed button 1 was depressed approximately 2/3 of its total travel and button 2 was not depressed.The syringe was received connected to the device with the stopcock open.In addition, an unknown procedure sheath was locked on to the sheath catch and blood was noted in the procedure sheath.The sealant was found exposed from the sealant sleeves due to a severely kinked/bent condition however, no cracks were observed on it.Functional testing was performed on the returned device and button 1 was manually reset to the factory setting.Buttons #1 and #2 were able to be fully depressed, no resistance was felt and they locked in place as intended.The returned procedure sheath was removed from the device and an applicable lab introducer sheath was used to perform the insertion/withdrawal test on the returned vcd.The device was inserted/advanced through the lab introducer sheath with resistance felt.Visual inspection at high magnification showed the sealant was exposed from the sealant sleeves, which were kinked/bent outward.No cracks were observed.The reported ¿mynx control button 1- frozen/locked¿ was not confirmed.No issues were noted with respect to button 1 deployment during the investigation.The reported ¿mynx control system ~ resistance/friction with csi¿ was confirmed.Resistance was felt while advancing the device through a lab introducer sheath.Additionally, the malfunction ¿mynx control system-deployment difficulty-premature¿, was confirmed.The sealant was exposed because of the kinked/bent sealant sleeves.Based on the information available for review and product analysis, procedural/handling factors likely contributed to the kinked condition and the subsequent premature exposure of the sealant as well as the resistance felt on insertion.It should be noted that the mynx control device is manufactured with the outer sealant sleeve assembly at the distal end of the catheter cartridge tubing.The outer sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sealant sleeve assembly and is protected from being exposed prematurely.If the sealant sleeve is damaged/shredded during handling or device insertion into the sheath, that could cause the sealant to be exposed prematurely and obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the instructions for use (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.¿ the product analysis does not suggest the reported failure 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: 18324948
• MDR Text Key: 330957022
• Report Number: 3004939290-2023-03533
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: NOT AVAILABLE