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 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the outer sleeve of a 5f mynx control vascular closure device (vcd) was identified to have an abnormal split during the preparation procedure.The abnormal split in the outer sleeve is referring to the manufactured design slit in the distal end of the sealant sleeve.Hemostasis was achieved by another mynx device.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).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 or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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.The procedural sheath was not returned for evaluation and the syringe was received separated from the device, and the stopcock was observed closed.In addition, the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves, which were observed to have been kinked bent outward as received; however, no cracks were observed on it.The device was inspected for damages/anomalies that may have contributed to the reported failure, and no damages/anomalies were observed with the returned device.A dimensional test was not performed on the returned device due to the damages to the sealant outer sleeve assembly as received.Per functional analysis, 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be depressed to deploy the sealant with no resistance felt.Button 2 was also depressed, and the balloon was completely withdrawn into the tamp tube.No issues were noted with respect to button 1 and 2 deployment during the device failure investigation.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found exposed from the sealant sleeves due to the kinked/bent outward condition as received with no cracks observed on it.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, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ 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 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 are possible.It should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing and is not a product defect.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, it could cause the sealant to be exposed swollen prematurely.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.¿ 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.

Event Description

As reported, the outer sleeve of a 5f mynx control vascular closure device (vcd) was identified to have an abnormal split during the preparation procedure.The abnormal split in the outer sleeve is referring to the manufactured design slit in the distal end of the sealant sleeve.Hemostasis was achieved by another mynx device.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: per product evaluation, the sealant was found exposed from the sealant sleeves due it was observed to have been kinked bent outward as received, however no cracks were observed on it.

• 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: 18958859
• MDR Text Key: 339244121
• Report Number: 3004939290-2024-00134
• 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: 03/22/2024

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: F2312101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• 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: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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; ANOTHER UNKNOWN MYNX DEVICE