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 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the sealant sleeves of a 5f mynx control vascular closure device (vcd) were partially peeled off and the device could not enter a 5f non-cordis catheter sheath introducer (csi).It was also reported that the vascular puncture was above the femoral head; however, hemostasis was achieved via 20 minutes of manual compression.There was no reported injury to the patient.The damage to the sealant sleeves was observed during preparation.The device was stored and prepped according to the instructions for use (ifu) without difficulty; however, the mynx vcd was not purged of air during preparation.The storage of the device did not exceed 25 degrees celsius and there were no anomalies noted prior to use.The vessel diameter was verified to be greater than or equal to 5mm and there was no calcium, plaque, or tortuosity at the access site.The physician was mynx certified.There were no kinks in the sheath after its removal and no unusual force was applied during retraction.There was no damage to the deployment button and the button was not pressed at all.The device will be returned for evaluation.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 and the with the stopcock was found open.The sealant sleeve assembly was observed to have been severely kinked/bent outward as received.Additionally, the sealant sleeves were not fully covering the sealant, however, the sealant was not exposed to blood.A dimensional test was not performed on the returned device due to the damages in the sealant outer sleeve assembly as received.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control instructions for use (ifu).Some resistance was felt when attempted to depress the button #1 as received, however, button 1 was able to be depressed to deploy the sealant.No other issues were noted with respect to button 1 deployment during the device failure investigation.The returned device performed as intended per the mynx control ifu.Visual inspection at high magnification revealed that the sealant sleeve assembly was observed to have been severely kinked/bent outward as received.Additionally, the sealant sleeves were not fully covering the sealant, however, the sealant was not exposed to blood.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed; however, a kinked/bent condition was observed during analysis.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ as the sealant sleeves were not fully covering the sealant and an exposed sealant was detected.The exact cause of the observed condition could not be conclusively determined during analysis.Based on the information available for review and product analysis, the device was received in poor condition with the sealant sleeves severely kinked and bent outward.It is likely handling of the device, procedural factors, and sheath conditions (although not returned) may have been contributing factors to the damages visualized on the sealant sleeves.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.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.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.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.¿ the product analysis does not suggest the issue experienced could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

Event Description

As reported, the sealant sleeves of a 5f mynx control vascular closure device (vcd) were partially peeled off and the device could not enter a 5f non-cordis catheter sheath introducer (csi).It was also reported that the vascular puncture was above the femoral head; however, hemostasis was achieved via 20 minutes of manual compression.There was no reported injury to the patient.The damage to the sealant sleeves was observed during preparation.The device was stored and prepped according to the instructions for use (ifu) without difficulty; however, the mynx vcd was not purged of air during preparation.The storage of the device did not exceed 25 degrees celsius and there were no anomalies noted prior to use.The vessel diameter was verified to be greater than or equal to 5mm and there was no calcium, plaque, or tortuosity at the access site.The physician was mynx certified.There were no kinks in the sheath after its removal and no unusual force was applied during retraction.There was no damage to the deployment button and the button was not pressed at all.The device will be returned for evaluation.Addendum: product evaluation revealed that the sealant was prematurely exposed.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18265731
• MDR Text Key: 329719109
• Report Number: 3004939290-2023-03517
• 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
• Type of Report: Initial
• Report Date: 12/05/2023

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 Catalogue Number: MX5060E
• Device Lot Number: F2313702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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