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

Catalog Number MX5021

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

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

Event Date 10/13/2023

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 5f mynx grip vascular closure device (vcd) burst during prep.Therefore, the product wasn¿t available and manual compression was performed for 20 minutes and recovered.There were no reports of patient injury.The mynx grip vcd was prepared and used in accordance with the instructions for use (ifu).The mynx vcd used in transfemoral cerebral angiography (tfca).There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.There was no excessive force used when removing the device from its packaging.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynx grip vascular closure device (vcd) burst during prep.Therefore, the product wasn¿t available and manual compression was performed for 20 minutes and recovered.There were no reports of patient injury.The mynx grip vcd was prepared and used in accordance with the instructions for use (ifu).The mynx vcd used in transfemoral cerebral angiography (tfca).There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.There was no excessive force used when removing the device from its packaging.A non-sterile ¿mynxgrip vascular closure device 5f¿ was returned for evaluation.Per visual inspection, the shuttle was engaged to the black handle.The syringe and procedure sheath were received for evaluation and the stopcock was found open.The sealant and advancer tube remained in the manufacturing position.The balloon was received fully deflated.Visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.Additionally, the sealant was observed to be remaining in the manufacturing position.The reported ¿balloon-balloon loss of pressure¿ was confirmed.Balloon loss of pressure was caused by a longitudinal tear in the balloon.The exact cause of the issues experienced could not be determined.Based on the information available for review, it is not possible to determine what factors may have contributed to the loss of pressure reported.However, prepping/handling factors are likely related factors.According to the ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynxgrip 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, "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." the available information does not suggest that the reported failures 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: MYNXGRIP
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18223504
• MDR Text Key: 329435843
• Report Number: 3004939290-2023-03505
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: 10862028000403
• 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: 01/18/2024

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: MX5021
• Device Lot Number: F2318605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• 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