MAUDE Adverse Event Report: CORDIS SANTA CLARA MYNXGRIP VASCULAR CLOSURE DEVICE 5F; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problems Failure to Advance (2524); Separation Failure (2547); Failure to Fire (2610)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

A product history review is expected but not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after shuttling down a 5f mynxgrip vascular closure device (vcd) the advancer tube split and some sealant was visible.There was significant resistance shuttling down, and the advancer tube was engaged and visible and sealant was reportedly stuck on the tamp tube.Manual compression was done for 20 minutes for hemostasis.There was no reported patient injury.The device had followed normal deployment steps until after shuttling down when the scrub tech went to slide the sheath and shuttle back up.The device was used in a y-90 transcatheter therapy embolization using an antegrade approach.The device was stored according to the ifu.The device was used with a 5f non-cordis sheath.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath.There was normal vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.The staff reported excess force was applied when inserting the device into the sheath.There was resistance/friction experienced as the mynx vcd was advanced through the sheath.The sheath was not kinked or bent.The user shuttled down completely.No unusual force was applied when retracting the sheath.The device is not available for evaluation.

Manufacturer Narrative

As reported, after shuttling down a 5f mynxgrip vascular closure device (vcd) the advancer tube split and some sealant was visible.There was significant resistance shuttling down, and the advancer tube was engaged and visible and sealant was reportedly stuck on the tamp tube.Manual compression was done for 20 minutes for hemostasis.There was no reported patient injury.The device had followed normal deployment steps until after shuttling down when the scrub tech went to slide the sheath and shuttle back up.The device was used in a y-90 transcatheter therapy embolization using an antegrade approach.The device was stored according to the ifu.The device was used with a 5f non-cordis sheath.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath.There was normal vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.The staff reported excess force was applied when inserting the device into the sheath.There was resistance/friction experienced as the mynx vcd was advanced through the sheath.The sheath was not kinked or bent.The user shuttled down completely.No unusual force was applied when retracting the sheath.The product was not returned for analysis.A product history record (phr) review of lot f2229807 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿ shuttle advancement issue¿, ¿sealant stuck to device components¿, and ¿sealant failure to deploy¿ could not be confirmed as the product was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural factors, such as the sealant prematurely hydrating, increasing the profile, adhering to the device components, may have contributed to the reported event.According to the instructions for use which is not intended as a mitigation of risk, it instructs users to open the procedural sheath stopcock and confirm temporary hemostasis while pulling lightly on the device handle (to ensure the balloon is abutting the arteriotomy or venotomy).Failure to open the procedural sheath stopcock and/or high tension applied to the balloon catheter during the deploy sealant step can result in a tight seal at the tip of the sheath, and as the device is advanced, blood can be trapped inside the sheath and caused the sealant to hydrate prematurely, resulting in the reported incident.Neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: MYNXGRIP VASCULAR CLOSURE DEVICE 5F
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 16223691
• MDR Text Key: 307895798
• Report Number: 3004939290-2023-02857
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)241031(10)F2229807
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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: MX5021
• Device Lot Number: F2229807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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: 5F TERUMO PINNACLE SHEATH.
• Patient Age: 62 YR
• Patient Sex: Male