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

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 02/07/2024

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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sealant sleeves of the 5f mynx control vascular closure device (vcd) were split, preventing the operator from inserting it into the sheath, and the sealant was exposed.Hemostasis was achieved by manual pressure.There was no reported patient injury.The operator in charge of the device was certified in handling mynx, and there was no evident damage to the device prior to unpacking.The device had been stored and prepared in accordance with the instructions for use (ifu).The sheath was not flushed prior to attempting to insert the mynx.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h11 complaint conclusion: as reported, the sealant sleeves of the 5f mynx control vascular closure device (vcd) were split, preventing the operator from inserting it into the sheath, and the sealant was exposed.Hemostasis was achieved by manual pressure.There was no reported patient injury.The operator in charge of the device was certified in handling mynx, and there was no evident damage to the device prior to unpacking.The device had been stored and prepared in accordance with the instructions for use (ifu).The sheath was not flushed prior to attempting to insert the mynx.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ involved in the reported complaint was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that the button #1 and button #2 were not depressed.The procedural sheath was not returned; however, the syringe was connected to the device.The stopcock was set in the open position, and the balloon was not inflated.The sealant was in its manufactured position, fully covered by the sleeves.The sealant sleeves did not present any frayed, split, or torn condition the atraumatic tip did not present any damages or anomalies.No other outstanding details were noticed.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control ifu.The tension indicator was aligned manually before buttons 1 and 2 were able to be depressed to deploy the sealant and withdraw the balloon with no resistance felt.No issues were noted with respect to both buttons 1 and 2 deployment during the device failure investigation.The returned device performed as intended per the mynx control ifu.Per microscopic analysis, the sealant sleeves were inspected with a vision system to obtain a magnified image, observing that they did not present with any damages or anomalies.The reported events of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ and ¿mynx control system-deployment difficulty-premature¿ were not confirmed through analysis of the returned device since there were no frayed/split/torn condition noted to the sleeves and the sealant was fully contained within the device.The cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the failure experienced by the customer since there were no anomalies noted to the device.However, handling factors are likely.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.As warned in 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: 18999323
• MDR Text Key: 338896509
• Report Number: 3004939290-2024-00153
• 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: 05/31/2024

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 Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2329902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• 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: UNKNOWN SHEATH
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian