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

Catalog Number MX6760E

Device Problem Premature Activation (1484)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, while advancing the 6f/7f mynx control vascular closure device (vcd) through the unknown sheath, the user encountered resistance.The user attempted to address the issue by retracting the delivery shaft slightly and attempting to advance it again.However, resistance persisted.Eventually, the user decided to remove the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The 7f non-cordis sheath was not kinked/bent upon removal.There was no visible bend/damage in distal end of the balloon shaft after removal.Excess force was not applied during insertion.The device was stored and prepared according to the instructions for use (ifu).The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The deployer was mynx certified.The device was used in a transfemoral cerebral angiography (tfca) procedure with a retrograde approach.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 6f/7f¿ 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 syringe was received separated from the device, and the procedural sheath was not received for evaluation.In addition, the balloon was found fully deflated.Additionally, the sealant was found partially exposed from the sealant sleeves, which was observed to have been severely kinked/bent as received; however, no cracks were observed on it.Without the return of the involved procedural sheath, a physical evaluation to determine whether there was damage to the procedural sheath that could have contributed to the reported complaint could not be made.Therefore, an applicable lab sheath introducer was used to perform the insertion/withdrawal test on the returned product per the functional analysis.Resistance was felt due to the damages of the sealant outer sleeve assembly; however, once it passed the procedural sheath¿s valve, the device was able to be advanced though the sheath as intended per the mynx control ifu.Additionally, a simulated deployment test was performed with the returned device per the mynx control ifu, and button 1 was able to be fully depressed and locked in place with some resistance felt.It was revealed that the sealant was exposed to blood, which caused the resistance felt when attempting to depress button 1.Button 2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found partially exposed from the sealant sleeves due to the severely kinked/bent condition observed as received.However, no cracks were observed on it.A product history record (phr) review could not be conducted as a lot number was not provided.The reported event of ¿mynx control system-impeded¿ was not confirmed through analysis of the returned device since it was able to be inserted into the lab sample sheath during functional analysis; although resistance was experienced due to the severely kinked/bent condition of the sealant sleeve assembly.Additionally, a condition was noted with the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked/bent sleeves.The exact cause of the observed condition 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 (although it was reported that excess force was not applied), and/or the condition of the sheath (which was not returned; although access site had mild tortuosity) possibly contributed to the severely kinked/bent 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 is assembled with 2 side slit overlapping outer sleeves.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.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, that 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 reported 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, while advancing the 6/7f mynx control vascular closure device (vcd) through the unknown sheath, the user encountered resistance.The user attempted to address the issue by retracting the delivery shaft slightly and the attempting to advance it again.However, resistance persisted.Eventually, the user decided to remove the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The 7f non-cordis sheath was not kinked/bent upon removal.There was no visible bend/damage in distal end of the balloon shaft after removal.Excess force was not applied during insertion.The device was stored and prepared according to the instructions for use (ifu).The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The deployer is mynx certified.The device was used in a transfemoral cerebral angiography (tfca) procedure with a retrograde approach.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product analysis shows that the sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent as received.

• 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: 18222840
• MDR Text Key: 329913510
• Report Number: 3004939290-2023-03504
• 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: 11/28/2023

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: MX6760E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 7F TERUMO SHEATH; ANOTHER UNKNOWN MYNX DEVICE.