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 01/05/2024

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 protection sleeve of a 5f mynx control vascular closure device (vcd) was damaged and could not enter the 5f non cordis sheath; the sealant protection was split.The sealant was exposed.Hemostasis was achieved with another unknown mynx device.There was no reported patient injury.The device was attempted to be used for hemostasis in a percutaneous transluminal angioplasty (pta) procedure.The user is mynx certified.The device was used in the femoral artery and the vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.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 protection sleeve of a 5f mynx control vascular closure device (vcd) was damaged and could not enter the 5f non-cordis sheath; the sealant protection was split.The sealant was exposed.Hemostasis was achieved with another unknown mynx device.There was no reported patient injury.The device was attempted to be used for hemostasis in a percutaneous transluminal angioplasty (pta) procedure.The user was mynx certified.The device was used in the femoral artery and the vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button 1 and button 2 were not depressed with the stopcock closed, and the syringe was connected to the luer hub.The procedural sheath was not returned for analysis.The sealant remained in its manufactured position, swelled by the blood saturation.Also, a kinked condition was observed on the inner and outer sleeve, which exposed the sealant as the kinked condition on the sleeves did not cover the sealant.No damages or anomalies on the atraumatic wire were observed.No other outstanding details were noticed.Per dimensional analysis, the catheter working length was measured to be verified, and the dimensional analysis result was found within specification.However, the slit length was not verified due to the observed kink.Per microscopic analysis, visual inspection at high magnification using a vision system showed that the sealant sleeve assembly presented a kinked condition.The sealant remained in its manufactured position, swelled by the blood saturation.Due to this condition, the sealant was exposed.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a kinked/bent condition of the sleeves was noted.Additionally, the reported event of ¿mynx control system-deployment difficulty-premature¿ was confirmed due to the exposed sealant from the kinked sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the limited 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 using an incorrect insertion angle), 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/kinked 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: 18848378
• MDR Text Key: 337522227
• Report Number: 3004939290-2024-00101
• 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: 04/29/2024

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 Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2324903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• 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 MERIT MEDICAL PRELUDE SHEATH INTRODUCER,; UNKNOWN MYNX
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian