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

Catalog Number MX6721

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

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

As reported, two 6/7f mynxgrip vascular closure devices (vcd) had balloons that would not inflate.There was no reported patient injury.The account pulled the remaining mynxgrip devices in that box off the shelf for concerns that the integrity of the peg may be deteriorated.The device was not used in the patient because the balloon was tested before it entered the patient.Additional information was requested but not provided.The were not returned for evaluation as previously expected.Addendum: on product evaluation, a longitudinal tear was found in the balloon of each returned device.

Manufacturer Narrative

This report is related to medwatch# 3004939290-2023-03508.As reported, two 6f/7f mynxgrip vascular closure devices (vcd) had balloons that would not inflate.There was no reported patient injury.The account pulled the remaining seven (7) mynxgrip devices in that box off the shelf for concerns that the integrity of the polyethylene glycol (peg) may be deteriorated.Additional information was requested but not provided.A non-sterile mynxgrip vascular closure device 6f/7f involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle with the stopcock opened.The advancer tube and sealant were observed to have remained in their manufactured positions.The syringe was received connected to the device and procedural sheath was not returned with the device.In addition, the balloon was received fully deflated.Per functional analysis, leak testing was performed on the balloon of the device.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 returned device.The reported events of ¿balloon-inflation difficulty¿ were confirmed through analysis of the returned devices due to the leak found in the balloons that prevented inflation.Therefore, the additional condition of ¿balloon-balloon loss of pressure¿ was found due to the leaks.However, the exact cause of the reported leaks found in the balloons could not be conclusively determined during analysis.Based on the limited information available for review and product analyses, access site vessel characteristics (which was not provided) and/or concomitant device factors (although not returned) likely contributed to the issues found since this type of damage to the balloon can occur when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft), especially since there were no issues noted with the sterile devices received.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu states, ¿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: 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.As warned in the ifu, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ neither the product analyses, nor the information available for review suggest that the failures noted 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 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: 18236482
• MDR Text Key: 329331705
• Report Number: 3004939290-2023-03509
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX6721
• Device Lot Number: F2232601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Ethnicity: Non Hispanic