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 01/17/2024

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, the balloon of a 6f/7f mynxgrip vascular closure device (vcd) ruptured upon inflation during patient use.A new unknown mynx was opened and deployed successfully.There was no reported injury.The user is trained to the device.A 6f unknown sheath was used.Device was used arterially.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 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 mynx vcd was prepped according to the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery.There was no visible damage in distal end of the sheath after removal.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h11 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) ruptured upon inflation during patient use.A new unknown mynx was opened and deployed successfully.There was no reported injury.The user was trained to the device.A 6f unknown sheath was used.Device was used arterially.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 greater than or equal to 5mm in diameter.There was no vessel tortuosity and no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The mynx vcd was prepped according to the instructions for use (ifu).There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.There was no visible damage in distal end of the sheath after removal.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 separated from the device, and the stopcock was found opened.The sealant was received on the device and advancer tube was received in its manufactured position.The balloon was received fully deflated.Furthermore, a cordis procedural sheath was locked on the device with blood noted in it, and no damages were noted.Per functional analysis, an inflation/deflation test was performed to the balloon of the returned device; and during this evaluation, the balloon was fully inflated with pressure maintained.The balloon was successfully inflated and deflated in accordance with the mynxgrip ifu.Per microscopic analysis, upon visual inspection at high magnification, it was observed that the balloon pressure was effectively maintained and successfully deflated.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.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: 18685028
• MDR Text Key: 336210255
• Report Number: 3004939290-2024-00070
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2024

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: F2229904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 05/08/2024
• Supplement Dates FDA Received: 03/14/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: UNKNOWN MYNX, 6F UNKNOWN SHEATH
• Patient Sex: Female