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 01/15/2024

Event Type  malfunction  

Event Description

As reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) failed therefore, the doctor needed to compress manually.During testing, the balloon was inflated; everything looked normal.The relief valve came out and the balloon looked okay.When extracting the device to bring the plug forward, the device came off because the balloon deflated although the syringe was blocked.The sales rep then tested another device that wasn't used on the patient.The balloon was inflated and then the force of it tested and it was also losing pressure.There was no reported patient injury.The user is mynx certified.A 5f and then a 6f 10cm non cordis sheath was used.The femoral site was the common femoral artery with "pavk" and stents.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be approximately 5 mm in diameter.There was moderate vessel tortuosity and moderate presence of pvd / calcium in the vicinity of the puncture site.The used device, as well as the clean device that was tested, will both be returned for evaluation.

Manufacturer Narrative

This report is related to report #3004939290-2024-00076.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

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) failed; therefore, the doctor needed to compress manually.During testing, the balloon was inflated; everything looked normal.The relief valve came out and the balloon looked okay.When extracting the device to bring the plug forward, the device came off because the balloon deflated although the syringe was blocked.The sales rep then tested another device that wasn't used on the patient.The balloon was inflated and then the force of it tested, and it was also losing pressure.There was no reported patient injury.The user was mynx certified.A 5f and then a 6f 10cm non-cordis sheath was used.The femoral site was the common femoral artery with "pavk" and stents.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be approximately 5mm in diameter.There was moderate vessel tortuosity and moderate presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.Comp-2024-05600-2: 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.The syringe was received connected to the device, and the stopcock was found opened.The sealant and advancer tube remained in their manufactured positions.The procedural sheath was not returned with the device.In addition, the balloon was found fully deflated.Per functional analysis, an inflation/deflation test was performed on the balloon of the returned device; and during this evaluation, the balloon was fully inflated with pressure maintained.The balloon was able to be inflated/deflated as intended per the mynxgrip instructions for use (ifu).No leaks were detected during functional testing.Per microscopic analysis, visual inspection at high magnification revealed that the balloon was able to be inflated/deflated.No leaks were detected during the microscopic examination.The reported events of ¿balloon-balloon loss of pressure¿ and ¿balloon-balloon loss of pressure at prep¿ were not confirmed through analysis of the returned devices since the balloons passed functional analysis.The exact cause of the reported incidents could not be conclusively determined during analysis of the returned devices.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issues experienced since there was no rupture noted on either device.However, balloon prep and/or handling factors are possible.Although not intended as a mitigation, the mynx control ifu instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.It also states to check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Failure to purge the device of air during the prep phase and/or excessive tension applied to the catheter during pullback can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and cause the balloon to be pulled through the arteriotomy, which can be mistaken as a balloon rupture.Neither the product analyses, nor the information available for review 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
• 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: 18695520
• MDR Text Key: 336422830
• Report Number: 3004939290-2024-00077
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000417
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 05/01/2024

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 Model Number: N/A
• Device Catalogue Number: MX6721
• Device Lot Number: F2305902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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
• Treatment: 5F AND 6F TERUMO SHEATH
• Patient Sex: Male