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

Catalog Number MX5021

Device Problem Defective Component (2292)

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

Event Date 12/19/2023

Event Type  malfunction  

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.

Event Description

As reported, proper hemostasis was not achieved after using a 5f mynxgrip vascular closure device (vcd) after the device was removed from the patient's body.Hemostasis was achieved by manual compression, less than 30 minutes.There was no reported patient injury.The device was used in a diagnostic procedure with a retrograde approach.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 5 mm in diameter.There was little vessel tortuosity.There was no presence of pvd / calcium in the vicinity of the puncture site.There was no visible damage to the distal end of the balloon shaft after removal.The sheath was not kinked/bent upon removal.There was no excess force applied during insertion.The user is trained to the device.The device was opened in a sterile field.The device was stored, used and prepared according to the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6 as reported, proper hemostasis was not achieved after using a 5f mynxgrip vascular closure device (vcd) after the device was removed from the patient's body.Hemostasis was achieved by manual compression, less than 30 minutes.There was no reported patient injury.The device was used in a diagnostic procedure with a retrograde approach.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 5 mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.There was no visible damage to the distal end of the balloon shaft after removal.The sheath was not kinked/bent upon removal.There was no excess force applied during insertion.The user is trained to the device.The device was opened in a sterile field.The device was stored, used and prepared according to the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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, and the stopcock was observed open.The syringe and the procedural sheath were not received for evaluation.The sealant and advancer tube were not returned with the device.The condition of the returned product indicates a complete removal of the device.No visual damages or anomalies were observed.Per functional analysis, the condition of the returned product indicates a complete removal of the device.In addition, the sealant and advancer tube of the returned device were not returned for evaluation.Therefore, no functional test could be performed on the returned device.Per microscopic analysis, visual inspection at high magnification showed the slit presence in the outer cartridge.In addition, the sealant was not received for evaluation.The reported ¿failure to achieve hemostasis¿ was not confirmed through analysis of the returned device due to the nature of the complaint.The exact cause of the issue experienced by the customer could not be determined during analysis.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 event reported since the device was returned in a condition that suggests a complete removal of the device (sealant and advancer tube were not received) with no damages/anomalies noted that could contribute to the reported failure.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.Neither the product analysis, nor the information available for review 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: 18552092
• MDR Text Key: 333355152
• Report Number: 3004939290-2024-00041
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: 10862028000403
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5021
• Device Lot Number: F2304501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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