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 01/24/2024

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 user was unable to insert a 5f mynx control vascular closure device (vcd) into a 5f non-cordis sheath through the sheath valve, as the sealant swelled in advance and could not pass through the sheath.The sealant was prematurely exposed/deployed during insertion into the sheath.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored, handled and prepped per the instructions for use (ifu).There were no damages noted to the packaging of the device prior to use.The device was removed from the package per the ifu.The device storage temperature did not exceed 25 °c.The mynx was used in a carotid artery stenting procedure, where a retrograde approach was made.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 5 mm in diameter.There was little vessel tortuosity.There was no presence of pvd / calcium in the vicinity of the puncture site.The sealant sleeves (cartridge assembly) were not out of position.There were no damages noted to the sealant sleeves (cartridge assembly).The deployer was certified in the use of the mynx device.There was no peripheral vascular disease in the vicinity of the puncture site.There was no exposure of the sealant to body fluids.The device is expected to be returned for analysis.

Manufacturer Narrative

As reported, the user was unable to insert a 5f mynx control vascular closure device (vcd) into a 5f non-cordis sheath through the sheath valve, as the sealant swelled in advance and could not pass through the sheath.The sealant was prematurely exposed/deployed during insertion into the sheath.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no damages noted to the packaging of the device prior to use.The device was removed from the package per the ifu.The device storage temperature did not exceed 25 °c.The mynx was used in a carotid artery stenting procedure, where a retrograde approach was made.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 5 mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The sealant sleeves (cartridge assembly) were not out of position and there were no damages noted.The deployer was certified in the use of the mynx device.There was no peripheral vascular disease in the vicinity of the puncture site.There was no exposure of the sealant to body fluids.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that both button 1 and button 2 were not depressed, and the stopcock was observed opened.The procedural sheath was received connected to the device and the syringe was not returned for evaluation.In addition, the balloon was found fully deflated.The sealant was found in its manufactured position, fully covered by the sealant sleeves, and exposed to blood.The sealant sleeves were observed to have been slightly kinked/bent.Per functional analysis, without the return of the procedural sheath, an applicable lab sample sheath was used to perform the insertion/withdrawal test on the returned product.The device was able to be inserted/advanced through the lab sample sheath without issue during the device failure investigation.In addition, a 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 revealed that the sealant was found in its manufactured position fully covered by the sealant sleeves.The sealant sleeves were observed to have been slightly kinked/bent; however, no frayed/split/torn conditions were observed on the device.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 on the lab sample sheath.Additionally, the reported event of ¿mynx control system-deployment difficulty-premature¿ was not confirmed since the sealant was in its manufactured position and fully covered by the sealant sleeves even though they were slightly kinked/bent.The cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the failure experienced.However, handling factors are possible, especially since the sealant was found exposed to blood and the sleeves were slightly kinked.It should be noted that the slits in the sealant sleeve assembly are not a product defect.The mynx control device is manufactured with the sealant sleeve assembly at the distal end of the catheter cartridge tubing.The 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 sealant sleeve assembly and is protected by the sealant sleeve assembly from being exposed prematurely.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.If the sealant sleeve is damaged/kinked during the device insertion into sheath, that could cause the sealant exposed/swelled, and/or obstruct the device path and prevent the device from being inserted into the procedure 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 issue experienced by the customer 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: 18766465
• MDR Text Key: 336082107
• Report Number: 3004939290-2024-00082
• 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: 05/01/2024

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: F2329902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian