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

Catalog Number MX6760

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 distal sealant sleeve of a 6/7f mynx control vascular closure device (vcd) was frayed and the sealant was visible.The defect was noted out of the packaging and was never inserted in the patient.Hemostasis was achieved by another mynx.There was no reported patient injury.The device inspected prior to use.The mynx vcd was used in interventional procedure with an antegrade approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was accidentally thrown out; therefore, it will not be returned for evaluation.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ and ¿mynx control system-deployment difficulty-premature¿ could not be confirmed as the device was not returned for analysis.The exact cause of the observed condition could not be determined.Based on the information available for review, it is not possible to determine what factors may have contributed to the issue reported.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.¿ based on the information available for review, there is no indication that the event is related to the design or manufacturing process of the unit.Therefore, no corrective or preventative action will be taken at this time.

Event Description

As reported, the distal sealant sleeve of a 6/7f mynx control vascular closure device (vcd) was frayed and the sealant was visible.The defect was noted out of the packaging and was never inserted in the patient.Hemostasis was achieved by another mynx.There was no reported patient injury.The device inspected prior to use.The mynx vcd was used in interventional procedure with an antegrade approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was accidentally thrown out; therefore, it will not be returned for evaluation.

Manufacturer Narrative

The correct aware date is 2-jan-2024.

• 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: 18521799
• MDR Text Key: 333128835
• Report Number: 3004939290-2024-00025
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: MX6760
• Device Lot Number: F2330602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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