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 11/28/2023

Event Type  malfunction  

Event Description

As reported, the sealant protection distal tip of a 5f mynx control vascular closure device (vcd) was broken and the device could not enter the 5f non-cordis sheath.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu).There were no visible signs of device/package damage prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30~45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no vessel tortuosity.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 thirty 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 mynx vcd used in transfemoral cerebral angiography (tfca) with a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product evaluation revealed that the sealant remained in the manufacturing position exposed due to the conditions of the sealant outer sleeve assembly that presented damaged evidence that could be related to the reported event.Visual inspection at high magnification, showed that the sealant outer sleeve assembly damaged evidence that could be described as a frayed/split/torn condition.

Manufacturer Narrative

Complaint conclusion: as reported, the sealant protection distal tip of a 5f mynx control vascular closure device (vcd) was broken and the device could not enter the 5f non-cordis sheath.Therefore, the product was not available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.The mynx control vessel closure unit was prepared and used in accordance with instructions for use (ifu).There were no visible signs of device/package damage prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no vessel tortuosity.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 thirty 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 mynx vcd used in transfemoral cerebral angiography (tfca) with a retrograde approach.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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 button 1 and button 2 were not depressed.The sealant remained in its manufactured position exposed due to the conditions of the sealant outer sleeve assembly that presented evidence of damage that could be related to the reported event.The exposed sealant condition resulted in a swelled sealant condition that was completely covered in blood.The sheath used in the procedure was not returned with the device to be evaluated.Dimensional analysis of the slit length could not be measured due to the conditions of the observed device.A functional test for introduction/withdrawal into the catheter sheath introducer (csi) could not be executed due to the conditions of the sealant sleeves.Additionally, due to the exposure condition observed with the sealant that could be concluded as premature deployment malfunction, a deployment mechanism simulation was performed.During the deployment simulation, the device received showed that the deployment mechanism was not compromised.After depressing button 1 and 2 in the unit, the sealant was deployed and the balloon was fully retracted as expected, per the unit¿s intended use mechanism.Per microscopic analysis, visual inspection at high magnification showed that the sealant outer sleeve assembly damages could be described as a frayed/split/torn condition.The reported event of ¿sealant sleeves (cartridge assembly)-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, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the damaged sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the 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 damaged condition of the sealant sleeves, the impedance experienced during insertion, 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.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 failures 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: 19003285
• MDR Text Key: 338896264
• Report Number: 3004939290-2024-00154
• 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: 03/29/2024

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: F2324903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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