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 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, while attempting to insert a 5f mynx control vascular closure device (vcd) into an unknown sheath, resistance was felt and the device could not reach the patient's arteriotomy.Hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.There was no reported patient injury.The device was used during transfemoral cerebral angiography using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.The vcd was prepared according to the instructions for use.Additional patient and procedural details were requested but were not available.The device was stored per the instructions for use (ifu).The vcd was used with a 5f non-cordis sheath.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.The sheath was not kinked or bent upon removal.No excess force was applied during insertion.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe was received connected to the device, and the procedural sheath was not received for evaluation.The stopcock was observed opened.In addition, the balloon was found fully deflated, and the sealant was found slightly exposed from the sealant sleeves.No damages were observed to the sealant sleeves assembly.Per functional analysis, without the return of the procedural sheath, an applicable lab sample catheter sheath introducer (csi) was used to perform the insertion/withdrawal test on the returned product, and the device was able to be inserted/advanced through the csi without issue during the device failure investigation.The returned device performed as intended per the mynx control instructions for use (ifu).In addition, simulated deployment test was performed on the returned device per the mynx control ifu, step 2: deploy sealant.Button 1 was able to be depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1 deployment during the device failure investigation.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.The returned device performed as intended per the mynx control ifu.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found slightly exposed from the sealant sleeves.No damages were observed to the sealant sleeves assembly.The reported event of ¿mynx control system-impeded¿ was not confirmed through analysis of the returned device since the device passed functional analysis with the insertion/withdraw test.However, an additional condition of ¿mynx control system-deployment difficulty-premature¿ was noted due to the slightly exposed sealant.The exact cause of the issues experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to the slightly exposed sealant noted during visual analysis.However, handling factors are possible.It should be noted that the mynx control device is manufactured with slits 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 during prepping phase and/or insertion into the 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.However, regarding the reported difficulty experienced when attempting to insert the device into the sheath, it is not possible to determine what factors may have contributed to impedance experienced since the device passed functional analysis with no resistance and the procedural sheath was not returned for investigation.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 product analysis, nor the information available for review suggest that the reported failure and noted condition 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, while attempting to insert a 5f mynx control vascular closure device (vcd) into an unknown sheath, resistance was felt and the device could not reach the patient's arteriotomy.Hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.There was no reported patient injury.The device was used during transfemoral cerebral angiography using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.The vcd was prepared according to the instructions for use.Additional patient and procedural details were requested but were not available.The device was stored per the instructions for use (ifu).The vcd was used with a 5f non-cordis sheath.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.The sheath was not kinked or bent upon removal.No excess force was applied during insertion.The device will be returned for evaluation.Addendum: product analysis demonstrates the sealant was found slightly exposed from the sealant sleeves.

• 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: 19010739
• MDR Text Key: 339043674
• Report Number: 3004939290-2024-00155
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 04/01/2024

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
• Device Lot Number: F2325401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian