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

Catalog Number MX5060

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

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

Event Date 05/24/2023

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.

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) popped prior to insertion into the sheath while prepping it.There was no reported patient injury.Additional information was requested but not provided.The device is being returned for evaluation.

Manufacturer Narrative

The balloon of a 5f mynx control vascular closure device (vcd) popped prior to insertion into the sheath while prepping it.There was no reported patient injury.The product was returned for analysis.A non-sterile mynx control vcd 5f was returned for investigation inside a clear plastic bag.Per visual analysis both button 1 and button 2 were not depressed.The syringe was received connected to the device and procedure sheath was not received for evaluation.The stopcock was observed open.The balloon was found fully deflated.In addition, the sealant was found in the manufacturing position fully covered by the sealant sleeves and no damages were noted in the sealant sleeves.Per functional analysis an inflation/deflation test was performed (mynx control instructions for use (ifu),) the results revealed a leak in the balloon of the returned device.Per microscopic analysis a longitudinal tear was noted in the balloon of the return device and the sealant was found in the manufacturing position fully covered by the sealant sleeves and no damages were noted in the sealant sleeves.The reported ¿mynx control balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) may have contributed to the event as the presence of calcification is known to cause damage to balloons and a longitudinal tear was found during analysis.According to the instructions for use, which is not intended as a mitigation of risk, users are instructed not to use the device if the balloon does not maintain pressure.Neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action 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: 18159646
• MDR Text Key: 328600565
• Report Number: 3004939290-2023-03494
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: 20862028000424
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5060
• Device Lot Number: F2310101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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