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 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, when the user tried to advance a 5f mynx control vascular closure device (vcd) through the 5f non-cordis sheath, the outer sleeve struck the edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.There was no reported patient injury.The device was stored and prepped as per the instructions for use (ifu).The user is mynx certified.A non-sterile mynx control vascular closure device 5f was returned for evaluation.Visual inspection of the received device showed buttons 1 and 2 were not depressed.The sealant remained in the manufacturing position exposed and swelled as the sealant sleeve assembly showed evidence related to a frayed/torn condition directly related to the exposure of the sealant.No sheath was returned with the device for this evaluation and the syringe was attached to the device.The condition of the returned device did not permit the measurement of the slit.The catheter sheath introducer (csi) introduction simulation was not possible due to the condition of the device.Nevertheless, the deployment mechanism was tested by depressing both buttons and no issues were present on the mechanism of the device.The reported ¿sealant sleeves (cartridge assembly) ¿ frayed/split/torn¿ and ¿mynx control system ¿ deployment difficulty ¿ premature¿ were confirmed.The sealant was exposed because of the frayed/split/torn condition.Based on the information available for review and product analysis, procedural/handling factors likely caused the damages and the subsequent premature exposure of the sealant.It should be noted that the mynx control device is manufactured with the outer sealant sleeve assembly at the distal end of the catheter cartridge tubing.The outer sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sealant sleeve assembly and is protected from being exposed prematurely.If the sealant sleeve is damaged/shredded during handling or device insertion into the sheath, that could cause the sealant to be exposed prematurely and obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the instructions for use (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 reported failure 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, when the user tried to advance a 5f mynx control vascular closure device (vcd) through the 5f non cordis sheath, the outer sleeve struck the edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.There was no reported patient injury.The device was stored and prepped as per the instructions for use (ifu).The user is mynx certified.The device will be returned for analysis.Addendum: product analysis showed evidence related to a frayed/torn condition directly related to the exposure of the sealant.

• 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: 18427529
• MDR Text Key: 331879172
• Report Number: 3004939290-2024-00007
• 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: 01/02/2024

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: MX5060E
• Device Lot Number: F2320006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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 TERUMO SHEATH.