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

Catalog Number MX6721

Device Problem Defective Component (2292)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

As reported, a 6/7f mynxgrip vascular closure device (vcd) did not achieve proper hemostasis after the device was removed from the patient's body.There was pulsatile bleeding of the puncture site immediately noted upon removal of the advancer tube.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).There was no damage to the device prior to opening the package.The mynx vascular closure device was prepared and used according to the instructions for use (ifu).There were no issues noted during balloon retraction / button#2 step.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 7f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.The mynx vcd was used in an interventional procedure with a retrograde approach used.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be 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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, a 6/7f mynxgrip vascular closure device (vcd) did not achieve proper hemostasis after the device was removed from the patient's body.There was pulsatile bleeding of the puncture site immediately noted upon removal of the advancer tube.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).There was no damage to the device prior to opening the package.The mynx vascular closure device was prepared and used according to the instructions for use (ifu).There were no issues noted during balloon retraction / button#2 step.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 7f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.The mynx vcd was used in an interventional procedure with a retrograde approach used.The deployer is mynx certified.A non-sterile mynxgrip vascular closure device 6/7f was returned for investigation.Visual inspection showed the shuttle was engaged to the black handle with the stopcock open.The syringe was connected to the device.The procedural sheath was not returned for the evaluation.Neither the sealant nor the advancer tube was returned which suggests full device deployment.The device was inspected for damages and it was observed the sleeves were separated before this unit was returned to the cordis lab.The device showed evidence of a provoked segmentation to the distal portion of the black shuttle, which prevented dimensional analysis from being successfully performed.Visible scratch marks were observed on the segmentation borders.These types of scratch marks are commonly attributed to surface interaction with sharp edged materials.The simulated deployment test could not be executed to ensure functionality of the returned device as the advancer tube and sealant were not returned.The balloon could not be inflated as traces of solution were observed in the proximal section of the inflation lumen, which impeded the passage of water to complete the balloon inflation.Visual inspection at high magnification showed the sealant was not present in the manufacturing position.This suggests possible sealant deployment prior to returning the device for analysis.The reported ¿failure to achieve hemostasis¿ was not confirmed due to the condition of the returned device.The exact cause of the issue experienced by the customer could not be determined.Based on the information available for review and product analysis, it is difficult determine what factors may have contributed to the failure to achieve hemostasis since the device was returned in a condition that suggests the device was completely removed.However, patient factors, pharmacological factors and/or handling factors of the device are possible.Failing to achieve hemostasis immediately after vascular closure is a common procedural complication and are frequently related to stick technique, anticoagulation, blood pressure, adequate sheath removal technique, and proper placement of the sealant at the arteriotomy.According to the product¿s ifu, which is not intended as a mitigation, users are informed to maintain fingertip compression on the skin during removal of the advancer tube from the tissue tract and to continue to apply fingertip compression for up to 1 minute or as needed.If hemostasis is not achieved, the user is informed to apply additional compression as necessary.The product analysis does suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventive 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: 18372636
• MDR Text Key: 331369024
• Report Number: 3004939290-2023-03544
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: F2309603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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: 7F TERUMO SHEATH