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

Catalog Number MX6721

Device Problems Positioning Failure (1158); Separation Failure (2547)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

As reported, the physican had difficulties trying to deploy a 6/7f mynxgrip.The physican said the sealant never came out but was stuck in the system.There was no reported injury to the patient.The product and packaging information was saved for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

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.

Event Description

As reported, the physican had difficulties trying to deploy a 6/7f mynxgrip.The physican said the sealant never came out but was stuck in the system.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

Manufacturer Narrative

As reported, the physician had difficulties trying to deploy a 6f/7f mynxgrip vascular closure device (vcd).The physician said the sealant never came out but was stuck in the system.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.The device was not returned for analysis.The product history record (phr) review of lot f2309401 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported events of ¿sealant-failure to deploy¿ and ¿sealant-sealant stuck to device components¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue reported could not be determined.Based on the limited information available for review, it is difficult to determine what factors may have contributed to the reported issues.However, it could be related to procedural/handling factors, such as incomplete shuttling down of the shuttle or premature swelling of the sealant, which can cause issues during deployment.According to the 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 phr review, nor the information provided, suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Event Description

As reported, the physican had difficulties trying to deploy a 6/7f mynxgrip.The physican said the sealant never came out but was stuck in the system.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.

Event Description

As reported, the physician had difficulties trying to deploy a 6/7f mynxgrip.The physician said the sealant never came out but was stuck in the system.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

Manufacturer Narrative

As reported, the physician had difficulties trying to deploy a 6f/7f mynxgrip vascular closure device (vcd).The physician said the sealant never came out but was stuck in the system.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.A non-sterile mynxgrip vascular closure device 6f/7f 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 with stopcock opened.The syringe was returned along with the cordis procedural sheath attached to the device.The advancer tube was returned in its manufactured position; however, the sealant was observed exposed on the distal portion of the catheter, attached to the unit.It is possible that handling or procedural factors could affect the state of the device when it was sent back to the cordis laboratory site.Nevertheless, the condition of the returned device likely indicates that the device was attempted to be deployed.No visual damages or other anomalies were observed.Per functional analysis, the sealant deployment mechanism was tested to verify the correct configuration of the device as received.The results obtained show that there were no problems in the device¿s deployment mechanism that could be confirmed as it was able to be actioned as expected by advancing the advancer tube and concluding the sealant detachment.The product history record (phr) review of lot f2309401 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported events of ¿sealant-failure to deploy¿ and ¿sealant-sealant stuck to device components¿ were confirmed through analysis of the returned device based on observed conditions during visual inspection.However, the exact cause of the issues experienced by the customer could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is difficult to determine what factors may have contributed to the reported issues.However, procedural/handling factors, such as incomplete shuttling down of the shuttle and/or premature swelling of the sealant may have contributed to the issues experienced since the sealant was deployed/adhered to the distal portion of the catheter with the advancer tube in its manufactured position.According to the 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, the phr review, nor the information provided 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): 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, california 95054 ; 7863138372
• MDR Report Key: 17662455
• MDR Text Key: 322412497
• Report Number: 3004939290-2023-03331
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)250430(10)F2309401
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX6721
• Device Lot Number: F2309401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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