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 10/04/2023

Event Type  malfunction  

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.

Event Description

As reported, the sealant sleeves of a 5f mynx control vascular closure device (vcd) were cracked and could not enter the sheath.Therefore, the product wasn¿t available and manual compression was performed for 20 minutes for hemostasis.There was no reported patient injury.The vcd was used in transfemoral cerebral angiogram.The procedure used a retrograde approach.The mynx control vessel closure unit was prepped and used in accordance with ifu instructions.There were no visible signs of device or package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30~45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have any visible calcium or plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The device was used with a 5 french non-cordis sheath introducer.There was little vessel tortuosity.The device is being returned for evaluation.Addendum: product evaluation showed the sealant remained in the manufacturing position only partially covered by the sealant sleeves.

Manufacturer Narrative

As reported, the sealant sleeves of a 5f mynx control vascular closure device (vcd) were cracked and could not enter the sheath.Therefore, the product wasn¿t available and manual compression was performed for 20 minutes for hemostasis.There was no reported patient injury.The vcd was used in transfemoral cerebral angiogram.The procedure used a retrograde approach.The mynx control vessel closure unit was prepped and used in accordance with the instruction for use (ifu).There were no visible signs of device or package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have any visible calcium or plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The device was used with a 5 french non-cordis sheath introducer.There was little vessel tortuosity.A non-sterile mynx control vascular closure device 5f involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that the button 1 and button 2 were not depressed, the sealant remained in its manufactured position partially covered by the sealant sleeves which presented a visible split condition that could be related to the reported event.Exposure to blood was denoted during this unaided eye visual inspection, scenario to which the slit could be attributed as a pre-deployment swelling could be appreciated in the received sealant.No other damages/anomalies were observed on the returned device during visual inspection.Neither the syringe nor the sheath used in the procedure were returned for this evaluation.Due to the split condition, the dimensional analysis of the slit length could not be properly measured.Per functional analysis, a cordis lab sample applicable catheter sheath introducer (csi) was used for a functional insertion/ withdrawal test where no resistance or friction was perceived during introduction and removal into the csi used.A functional deployment mechanism test was executed due to the split condition observed in the sealant sleeves that resulted in the partial exposure of the sealant.The result for this functional test was the correct activation of the deployment mechanism and the retraction of the balloon.Per microscopic analysis, visual inspection at high magnification showed that the sealant¿s outer sleeve assembly showed that the sealant was swelled causing the sealant sleeves to open as these are designed to do when the sealant is intended to be deployed.The reported event of ¿sealant sleeves (cartridge assembly)-cracked¿ was not confirmed through analysis of the returned device; however, a visible split condition of the sleeves was noted.Additionally, the reported event of ¿mynx control system-deployment difficulty-premature¿ was confirmed due to the partially exposed sealant from the split sleeves due to the pre-swelling observed.The exact cause of the observed condition could not be conclusively determined during analysis.Based on the information available for review and product analysis, procedural/handling factors (such as excessive force), and/or the condition of the sheath (although not returned) may have contributed to the split condition of the sealant sleeves, the premature exposure of the sealant, and the subsequent impedance.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 slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.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, that 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 product analysis, nor the information available for review suggest that 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: 18425470
• MDR Text Key: 331926358
• Report Number: 3004939290-2024-00004
• 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: 01/08/2024

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: F2311702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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: 5F TERUMO SHEATH