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

Catalog Number MX6760E

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) was leaking and could not be inflated, after inserting through the unknown sheath.There was no reported patient injury.During preparation the mynx balloon was inflated and checked ok.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) was leaking and could not be inflated, after inserting through the unknown sheath.There was no reported patient injury.During preparation the mynx balloon was inflated, and it checked out ok.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 6f/7f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button 1 and button 2 were not depressed.The syringe and the non-cordis sheath used were returned for analysis.The stopcock was set in the open position.The sealant remained in its manufactured position, swelled by the blood saturation but not exposed.The atraumatic tip did not present any damages or anomalies.The sealant sleeves presented a kinked condition.The device was blood saturated.No other outstanding details were noticed.Per functional analysis, an inflation/deflation test was performed on the returned device to ensure the balloon¿s functionality according to the instructions for use (ifu).The results revealed a leak in the balloon.Per microscopic analysis, the balloon was inspected using a vision system to obtain a magnified image, and a pinhole was confirmed.In addition, a kink at the sealant sleeves was also observed.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the pinhole found could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is not possible to determine what factors may have contributed to the loss of pressure reported.However, handling factors (sealant sleeves were noted to be kinked/bent), access site vessel characteristics (although not reported) and/or concomitant device factors most likely contributed to the reported event since excessive force during use, a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon.According to the ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu instructs users to discard the device if the balloon does not maintain pressure.Neither the product analysis, nor the information available for review suggest that 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.

• 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: 18010566
• MDR Text Key: 326590258
• Report Number: 3004939290-2023-03440
• Device Sequence Number: 1
• Product Code: MGB
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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: MX6760E
• Device Lot Number: F2318803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2023
• 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