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 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Waybill received but device has not been received.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) burst during the preparation process.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

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.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynx control vascular closure device (vcd) burst during the preparation process.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 6f/7f¿ was returned for evaluation.Visual inspection of the received device showed both button 1 and button 2 were not depressed.The syringe and procedure sheath were not received for evaluation.The stopcock was observed closed.The balloon was found fully deflated.In addition, the sealant was found in the manufacturing position fully covered by the sealant sleeves and exposed to blood.For functional analysis, an inflation/deflation test was performed and a leak in the balloon was noted.Visual inspection under high magnification revealed a longitudinal tear in the balloon.The sealant was found in the manufacturing position fully covered by the sealant sleeves and exposed to blood.The reported ¿balloon-balloon loss of pressure¿ was confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.This type of tear is typically observed when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent, or vascular graft).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 reported event could be related to the manufacturing process of the unit.Therefore, no corrective 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: 17939685
• MDR Text Key: 325735686
• Report Number: 3004939290-2023-03427
• 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: 11/30/2023

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: F2308103
• 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; 11/21/2023
• Supplement Dates FDA Received: 11/08/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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.