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

Catalog Number MX5060E

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

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

Waybill received.Device has not been received yet.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was later returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe and the procedural sheath were not returned for evaluation.In addition, the stopcock was found opened.The sealant was found in its manufactured position fully covered by the sealant sleeves.However, it was noted to be swelled from exposure to blood.The balloon was noted fully deflated.Per functional analysis, an inflation/deflation test was performed per the mynx control instructions for use (ifu).The results revealed a leak in the balloon of the returned device.Per microscopic analysis, visual inspection at high magnification showed a longitudinal tear in the balloon of the returned device.The sealant was found in its manufactured position fully covered by the sealant sleeves; however, it was noted to be swelled from exposure to blood.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear 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, prepping/handling factors, access site vessel characteristics (although not reported) and/or concomitant device factors (although not returned) most likely contributed to the reported event since excessive force, 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 device preparation states, "inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and the syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate." 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.

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.

• 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: 17939721
• MDR Text Key: 325736071
• Report Number: 3004939290-2023-03428
• 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,Followup
• Report Date: 12/14/2023

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 Catalogue Number: MX5060E
• Device Lot Number: F2303701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 12/06/2023
• Supplement Dates FDA Received: 11/08/2023; 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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.