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

Catalog Number MX5021

Device Problems Separation Failure (2547); Failure to Fire (2610)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

As reported, the sealant of a 5f mynxgrip vascular closure device (vcd) did not deploy upon shuttling down.The sealant was stuck to the device components.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored and prepped according to the ifu.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The device was used with a 5f non-cordis sheath.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 moderate vessel tortuosity.There was little to no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.The user shuttled down completely.There was no significant resistance when shuttling down.No unusual force was applied when retracting the sheath.The advancer tube was visible.The storage temperature did not exceed 25°c.The device is being 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.

Manufacturer Narrative

As reported, the sealant of a 5f mynxgrip vascular closure device (vcd) did not deploy upon shuttling down.The sealant was stuck to the device components.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored and prepped according to the instructions for use (ifu).The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The device was used with a 5f non-cordis sheath.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 moderate vessel tortuosity.There was little to no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.The user shuttled down completely.There was no significant resistance when shuttling down.No unusual force was applied when retracting the sheath.The advancer tube was visible.The storage temperature did not exceed 25°c.A non-sterile ¿mynxgrip vascular closure device 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received 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 advancer tube was on the catheter shaft, and the sealant was not received for evaluation.The device was inspected for damages that may have contributed to the reported event, and no visual damages or anomalies were observed.Dimensional analysis was performed to verify the distance between the proximal and distal tamp locks, and measurements were noted to be within specification.The sealant of the returned device was not returned; therefore, a complete functional investigation could not be conducted.Per microscopic analysis, visual inspection at high magnification showed that the tamp locks were inspected for damages that may have prevented the advancer tube from engaging to the proximal tamp lock during the procedure, and no damages were found.The reported events of ¿sealant-failure to deploy¿ and ¿sealant-sealant stuck to device components¿ were not confirmed through analysis of the returned device since the sealant was not received for analysis and there were no anomalies noted to the device.The exact cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review, it is difficult to determine what factors may have contributed to the reported incident of the sealant failing to deploy/becoming stuck to the device, especially since there were no damages or other anomalies noted to the device and the sealant was not returned.However, procedural/handling factors (such as incomplete engagement of the advancer tube) are possible since it was reported that there was no resistance experienced during the shuttle down/sheath retraction step.According to the mynxgrip instructions for use (ifu), which is not intended as a mitigation, ¿while pulling lightly on the device handle (to ensure the balloon is abutting the arteriotomy or venotomy), open the procedural sheath stopcock and confirm temporary hemostasis.Detach shuttle and advance in a continuous motion until a definitive stop is felt.Immediately grasp the procedural sheath and withdraw it from the tissue tract.Continue retracting until the shuttle locks on the handle.¿ it should be noted that if the shuttle is not advanced until the advancer tube is engaged to the proximal tamp lock (definitive stop), this will cause the advancer tube and sealant to follow the shuttle cartridge back out of the tissue tract during the retraction step, resulting in the device failing to deploy.Neither the product analysis, nor the information available for review, suggest that the reported failures experienced could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventive action 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 ; 14021 nw 60 avenue; miami lakes, CA 33014 ; 7863138372
• MDR Report Key: 18290592
• MDR Text Key: 330041281
• Report Number: 3004939290-2023-03525
• Device Sequence Number: 1
• Product Code: MGB
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX5021
• Device Lot Number: F2327203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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 BOSTON SCIENTIFIC SHEATH
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 95 KG