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

Catalog Number MX5060

Device Problem Premature Activation (1484)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

As reported, it appeared the sealant sleevs of a 5f mynx control vascular closure device (vcd) were frayed and would not enter the sheath.Another mynx device was used for hemostasis.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The procedure used a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.The device is being returned for evaluation.Addendum: on product evaluation the sealant was found partially exposed from the sealant sleeves.

Manufacturer Narrative

As reported, it appeared the sealant sleeves of a 5f mynx control vascular closure device (vcd) were frayed and would not enter the sheath.Another mynx device was used for hemostasis.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The procedure used a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.A non-sterile ¿mynx control vcd 5f¿ was returned for analysis.Visual inspection of the received device showed buttons 1 and 2 were not depressed.The syringe and the procedure sheath were not returned.The stopcock was found open.The sealant was found partially exposed from the sealant sleeves, which have been severely kinked/bent.No cracks were observed on the sealant sleeves.Dimensional analysis could not be performed due to the severely kinked/bent sealant sleeve assembly.A simulated deployment test was performed on the returned device and 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 investigation.Button 2 was able to be fully depressed, and no issues were noted with respect to button 2 either.Visual inspection at high magnification revealed the sealant sleeves were kinked/bent which led to the partial exposure of the sealant.No cracks were observed.The reported, ¿sealant sleeves-frayed/split/torn¿ was not confirmed however, the sealant sleeve assembly was received severely kinked/bent.Additionally, the malfunction ¿mynx control system-deployment difficulty-premature¿, was confirmed as the sealant was exposed due to the kinked/bent condition of the 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.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: 18424903
• MDR Text Key: 331932067
• Report Number: 3004939290-2024-00002
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: 20862028000424
• 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: 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: MX5060
• Device Lot Number: F2325001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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