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 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

A 6f/7f mynx control vascular closure device (vcd) was removed because it was difficult to enter the unknown sheath.There was no reported patient injury.Addendum: product evaluation demonstrates that the sealant was found partially exposed from the sealant sleeves.The product was returned for analysis.A non-sterile ¿mynx control vcd 6f/7f¿ 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 was received separated of the device and the procedure sheath was not received for evaluation.The stopcock was observed open.In addition, the balloon was found fully deflated.Additionally, the sealant was found partially exposed from the sealant sleeves due it was observed to have been kinked/bent as received.Functional analysis- without the return of the procedure 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, and the device was able to be inserted/advanced through the lab introducer sheath without issue during the device failure investigation.The returned device performed as intended.In addition, 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.The returned device performed as intended per the mynx control ifu.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Microscopic analysis- visual inspection at high magnification showed that the sealant was found partially exposed from the sealant sleeves due it was observed to have been kinked/bent as received.The reported ¿mynx control system ~ impeded¿ was not confirmed due the insertion/withdrawal test on the returned product was performed without issue during the device failure investigation.In addition, per sealant condition received ¿mynx control system-deployment difficulty-premature¿, was confirmed, and the exact cause of this incident could not be determined from the information provided.During visual inspection of the returned device revealed that the sealant sleeve assembly component of the system was kinked/bent, which may have contributed to the reported incident.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.Procedural factors and handling process may have contributed to the reported events.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 issue experienced 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, a 6f/7f mynx control vascular closure device (vcd) was removed because it was difficult to enter the unknown sheath.There was no reported patient injury.The device will be returned for evaluation.Addendum: product evaluation demonstrates that the sealant was found partially exposed from the sealant sleeves.

• 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: 18289887
• MDR Text Key: 330034304
• Report Number: 3004939290-2023-03523
• 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: MX6760E
• Device Lot Number: F2316502
• 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: 11/20/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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: UNKNOWN SHEATH.