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 09/22/2023

Event Type  malfunction  

Event Description

As reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) was damaged; it was split.Therefore, the device couldn't enter the 5f non cordis sheath and manual compression was used.The damage to the sealant sleeve was noted after removal.Hemostasis was achieved by holding manual pressure for twenty minutes.There was no reported patient injury.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the ifu and no difficulty was noted.The mynx device was not purged of air during prep.The stick location was above the femoral head.The vessel diameter was verified to be greater than or equal to 5mm.The vessel was reported to have moderate tortuosity.There was no damage to the button.The button was not depressed at all.The device will be returned for evaluation.Addendum: product analysis demonstrates that the sealant was found partially exposed from the sealant sleeves.

Manufacturer Narrative

The sealant sleeve of a 5f mynx control vascular closure device (vcd) was damaged; it was split.Therefore, the device couldn't enter the 5f non cordis sheath and manual compression was used.The damage to the sealant sleeve was noted after removal.Hemostasis was achieved by holding manual pressure for twenty minutes.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the ifu and no difficulty was noted.The mynx device was not purged of air during prep.The stick location was above the femoral head.The vessel diameter was verified to be greater than or equal to 5mm.The vessel was reported to have moderate tortuosity.There was no damage to the button.The button was not depressed at all.There was no reported patient injury.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation inside a clear plastic bag.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe and the procedure sheath were not returned.The stopcock was found open.The sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent as received, however no cracks were observed on it.In addition, it was noted that there was crystallized residual in the balloon.Dimensional analysis could not be performed on the returned device due to the severely kinked/bent sealant sleeve assembly condition.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.An applicable lab introducer sheath was used to perform the insertion/withdrawal test on the returned product.Resistance was felt due to the damages in the sealant outer sleeve assembly and crystallized residual in the balloon however, once it passed the procedure sheath¿s valve, the device was able to be advanced though the sheath¿s lumen as intended per the mynx control instructions for use, lbl10152 rev 4.Simulated deployment test was performed on the returned device per the mynx control instructions for use (ifu), lbl10152_rev 4, 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 not able to be fully depressed since it was noted that on the balloon was crystallized residual, which may have contributed to the balloon was not completely withdrawing into the tube.Visual inspection at high magnification revealed that the sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent as received, however no cracks were observed on it.In addition, it was noted that there was crystallized residual in the balloon.The reported ¿sealant sleeves-frayed/split/torn¿ and mynx control system- impeded¿ were not confirmed.Visual inspection of the returned device revealed that the sealant sleeve assembly was found severely kinked/bent as received, which may have contributed to the reported incident.Resistance was felt due to the damages in the sealant outer sleeve assembly and crystallized residual in the balloon however when the insertion/withdrawal test was performed on the returned product.However, once it passed the procedure sheath¿s valve, the device was able to be advanced though the sheath¿s lumen.The reported ¿mynx control system-deployment difficulty-premature¿, was confirmed, and the exact cause of this incident could not be determined from the information provided.It should be noted that 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.Please note that the slits in the sealant sleeve assembly are not a product defect.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.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.According to the instructions for use (ifu) ¿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.¿ the product analysis does not suggest that the issues experienced 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 18289973
• MDR Text Key: 330037317
• Report Number: 3004939290-2023-03524
• 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: 12/08/2023

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 Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2312101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 12/08/2023
• 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 NON CORDIS SHEATH.