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

Catalog Number MX6721

Device Problem Separation Failure (2547)

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

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.This device is reported to not be available for analysis and no device has 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 plug of a 6f mynxgrip vascular closure device (vcd) came out and did not deploy correctly before closure.The plug deployed but stayed connected to the advancer tube/shuttle.The procedure was completed by holding manual pressure and hemostasis achieved.There was no reported patient injury.The user was mynx certified.A 6f non cordis sheath was used.The common femoral artery (cfa) was verified under angiography and insertion angle of 30-45 degrees was performed.The vessel "diameter" was 6mm.There was no tortuosity of the puncture site and no peripheral vascular disease (pvd) visualized at the access site.The shuttle did advance down completely.The device will not be returned for evaluation because it was discarded.

Manufacturer Narrative

Complaint conclusion: as reported, the plug of a 6f/7f mynxgrip vascular closure device (vcd) came out and did not deploy correctly before closure.The plug deployed but stayed connected to the advancer tube/shuttle.The procedure was completed by holding manual pressure and hemostasis achieved.There was no reported patient injury.The user was mynx certified.A 6f non cordis sheath was used.The common femoral artery (cfa) was verified under angiography and insertion angle of 30-45 degrees was performed.The vessel diameter was 6mm.There was no tortuosity of the puncture site and no peripheral vascular disease (pvd) visualized at the access site.The shuttle did advance down completely.The reported event of ¿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 information available for review, it is difficult to determine what factors may have contributed to the sealant becoming stuck to the advancer tube after sealant deployment.However, it is possible that the issue experienced could have been caused by the sealant swelling up prematurely, which can cause issues during deployment.Premature swelling of the sealant can occur when a high amount of tension is applied to the balloon catheter during the shuttle deployment step, which can result in a tight seal at the tip of the sheath.As the device is advanced, blood can be trapped inside the sheath due to the tight seal, causing the sealant to hydrate prematurely and contribute to the sealant sticking to the device/advancer tube.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.¿ no corrective or 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 17851345
• MDR Text Key: 324686167
• Report Number: 3004939290-2023-03395
• 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,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• 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: F2318802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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 PINNACLE SHEATH.
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 99 KG