MAUDE Adverse Event Report: CORDIS 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 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of two 6/f mynxgrip vascular closure devices (vcd) burst.Both devices failed in the same patient during a diagnostic peripheral procedure.Hemostasis was achieved by manual compression for 30 minutes or less.The burst occurred when pulling the mynx device back, to bring the balloon against the artery.The balloon lost pressure between the first and second stop.There was no reported patient injury.The femoral artery suitability was verified on angiography or venography including the insertion angle of the vascular sheath introducer.The vessel type was arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity and no presence of pvd / calcium in the vicinity of the puncture site.The device was stored as per the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery or vein.There was no damage noted in the distal end of the sheath after removal.The deployer is mynx certified.The device is expected to be return for evaluation.

Manufacturer Narrative

As reported, the balloon of two 6f/7f mynxgrip vascular closure devices (vcd) burst.Both devices failed in the same patient during a diagnostic peripheral procedure.Hemostasis was achieved by manual compression for 30 minutes or less.The burst occurred when pulling the mynx device back, to bring the balloon against the artery.The balloon lost pressure between the first and second stop.There was no reported patient injury.The femoral artery suitability was verified on angiography or venography including the insertion angle of the vascular sheath introducer.The vessel type was arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity and no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The device was stored as per the instructions for use (ifu).There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.There was no damage noted in the distal end of the sheath after removal.The deployer was mynx certified.The devices were discarded at site.Five (5) sterile unused mynxgrip 6f/7f devices from lot f2311801 were received for evaluation inside of their original box and sealed packages.During the visual inspection, all the units reviewed were found with no anomalies.Per functional analysis, leak testing was performed on the balloons of the five (5) units selected as a sample and no leak was found.Pressure was maintained with proper functioning of the inflation indicator per the mynxgrip ifu.In addition, after the leak testing, the balloon was able to deflate completely.The reported events of ¿balloon-balloon loss of pressure¿ could not be confirmed as the complaint devices were not returned for analysis.Additionally, the events were not confirmed when testing the sterile devices received since no anomalies were noted.The exact cause of the reported failures experienced by the customer could not be conclusively determined.Based on the information available for review and the product analyses, it is difficult to determine what factors may have contributed to the issues experienced since no issues were found with the balloon of the sterile devices during analysis.However, access site vessel characteristics (although reported to not have pvd/calcium in the vicinity of the puncture site) and/or sheath condition factors are possible since calcification/pvd at the access site or a frayed/damaged sheath tip can cause damage to the balloon, resulting in a loss of pressure.According to the mynxgrip 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 during product preparation, ¿confirm via femoral arteriogram or venogram: common femoral artery or vein 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.Neither the product analyses of the sterile units, nor the information available for review suggest that the reported failures 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): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara, california 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, california 95054 ; 7863138372
• MDR Report Key: 18059556
• MDR Text Key: 327212664
• Report Number: 3004939290-2023-03460
• 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,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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: F2311801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Date Device Manufactured: 04/28/2023
• 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