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

Catalog Number MX6760

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

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

This device is reported to be available for analysis but has not been documented as received at the time of this report, nor has any tracking information been able to be obtained.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) popped against the unknown sheath.Another 6f/7f mynx control from the same lot was used and also popped.There was no reported patient injury.The device was reported to be returned directly by the site to the manufacturer.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2,h6, and h11.Complaint conclusion: as reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) popped against the unknown sheath.Another 6f/7f mynx control from the same lot was used and also popped.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.The device was reported to be returned directly by the site to the manufacturer; however, it was never received for analysis.The reported events of ¿balloon-balloon loss of pressure¿ could not be confirmed as the devices were not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, access site vessel characteristics (although not reported) and/or concomitant device factors (balloons reportedly popped against the sheath) are likely since calcification at the access site and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon, and this occurred twice in the same puncture site/sheath.According to the mynx control instructions for use (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 prior to using the mynx control vcd: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the units.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: 19143837
• MDR Text Key: 340608764
• Report Number: 3004939290-2024-00198
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: F2335304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2023
• 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: UNKNOWN.