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

Catalog Number MX6721

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

As reported, the balloon of a 6/7f mynxgrip vascular closure device (vcd) lost pressure while inside the patient.The balloon lost pressure after being pulled to the arteriotomy.Hemostasis was achieved by manual pressure for less than thirty minutes.There was no reported patient injury.The mynx vcd was prepped according to instructions for use (ifu) instructions.The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in an interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned 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, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) lost pressure while inside the patient.The balloon lost pressure after being pulled to the arteriotomy.Hemostasis was achieved by manual pressure for less than thirty minutes.There was no reported patient injury.The mynx vcd was prepped according to the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 6f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The mynx vcd was used in an interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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 in the open position.The sealant was not received, and advancer tube was received removed from the device.The balloon was received fully deflated.Furthermore, the procedural sheath was not returned for evaluation, and the shaft assembly was observed kinked/bent as received.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 with proper functioning of the inflation indicator as intended per the mynxgrip ifu.Per microscopic analysis, it was observed that the balloon pressure was effectively maintained and successfully deflated upon visual inspection at high magnification.The reported event of ¿balloon-balloon loss of pressure¿ was not confirmed through analysis of the returned device since the balloon passed functional analysis and maintained pressure.The exact cause of the reported incident could not be conclusively determined during analysis.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced since there was no rupture noted, especially since the device was received deployed.However, prepping/handling factors are likely.Although not intended as a mitigation, the mynxgrip ifu instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.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/venotomy.The mynxgrip ifu step 2: deploy sealant, also instructs users to pull lightly on the device handle to ensure the balloon is abutting the vessel wall while withdrawing the procedural sheath from the tissue tract.If excessive tension is applied to the device during the sealant deployment step that can cause the balloon to be pulled through the arteriotomy.Neither the product analysis, nor the information available for review suggest that the reported failure is 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: 18989294
• MDR Text Key: 338758475
• Report Number: 3004939290-2024-00151
• 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: 03/27/2024

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: MX6721
• Device Lot Number: F2331406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Date Device Manufactured: 11/10/2023
• 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: 6F TERUMO SHEATH
• Patient Sex: Male