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

Model Number N/A

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

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

This device is reported to be available for analysis but has not been received at the time of this report.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f mynxgrip vascular closure device (vcd) kept air getting into the system somewhere and the balloon wasn¿t inflating properly and therefore, wasn't prepping correctly.A new one was pulled from the same box and it worked fine.There was no harm to the patient and no reported patient injury.The device was never inserted.The device is available 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, a 5f mynxgrip vascular closure device (vcd) kept air getting into the system somewhere and the balloon wasn¿t inflating properly and therefore, wasn't prepping correctly.A new one was pulled from the same box and it worked fine.There was no harm to the patient and no reported patient injury.The device was never inserted.A non-sterile ¿mynxgrip vascular closure device 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle, and the stopcock was found opened.The syringe and the procedural sheath were not returned with the device.The sealant and advancer tube were observed in their manufactured positions.In addition, the balloon was found fully deflated.Per functional analysis, leak testing was performed on the balloon of the returned device per the mynxgrip instructions for use (ifu).The results revealed a leak in the balloon.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.The reported event of ¿balloon-balloon loss of pressure at prep¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear condition 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 issue reported.However, as this issue was found during preparation of the device, handling factors during prep are possible.According to the ifu during the prepare balloon step, which is not intended as a mitigation, ¿fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and 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.

• Brand Name: MYNXGRIP
• 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: 18950767
• MDR Text Key: 338568619
• Report Number: 3004939290-2024-00128
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MX5021
• Device Lot Number: F2231204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2022
• 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: MYNXGRIP VCD