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 09/04/2023

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.

Event Description

As reported, the mynx grip vascular closure device was prepared and used according to the instructions for use (ifu), but proper hemostasis was not achieved after the device was removed from the patient's body.There was no reported injury to the patient.The device was stored and prepared according to the instructions for use.The device storage temperature did not exceed 25 °c.There was no difficulty noted during prep of the device.The deployer was certified in using the mynx device.There were no anomalies noted prior to use.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.The angle of access was between 30 and 45 degrees.There was no presence of pvd / calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The vessel was noted to have no tortuosity.There were no kinks on the 6f sheath after removal.Fingertip compression was maintained on the skin during removal of the device.It will be returned for analysis.

Event Description

As reported, the mynx grip vascular closure device was prepared and used according to the instructions for use (ifu), but proper hemostasis was not achieved after the device was removed from the patient's body.There was no reported injury to the patient.The device was stored and prepared according to the instructions for use.The device storage temperature did not exceed 25 °c.There was no difficulty noted during prep of the device.The deployer was certified in using the mynx device.There were no anomalies noted prior to use.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.The angle of access was between 30 and 45 degrees.There was no presence of pvd/calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The vessel was noted to have no tortuosity.There were no kinks on the 6f sheath after removal.Fingertip compression was maintained on the skin during removal of the device.It will be returned for analysis.

Manufacturer Narrative

The mynx grip vascular closure device was prepared and used according to the instructions for use (ifu), but proper hemostasis was not achieved after the device was removed from the patient's body.There was no reported injury to the patient.The device was stored and prepared according to the instructions for use.The device storage temperature did not exceed 25 °c.There was no difficulty noted during prep of the device.The deployer was certified in using the mynx device.There were no anomalies noted prior to use.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.The angle of access was between 30 and 45 degrees.There was no presence of pvd (peripheral vascular disease) / calcium in the vicinity of the puncture site.There was no scar tissue present in the vicinity of the puncture site.The vessel was noted to have no tortuosity.There were no kinks on the 6f sheath after removal.Fingertip compression was maintained on the skin during removal of the device.The product was returned for analysis.A non-sterile mynxgrip vascular closure device 5f was returned for investigation.Per visual analysis 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.The sealant was not returned as it was observed that the advance tube was distally protruded, evidence that could be related to a deployment attempt, therefore the sealant was not in manufacturing position.The device was inspected for damages that may have contributed to the reported event.No visual damages or anomalies were observed.Per functional analysis a simulated deployment test was executed to ensure functionality of the returned device.The shuttle was able to be advanced and retracted to the black handle without issue.The advancer tube was properly engaged to the proximal tamp lock during the device failure investigation.The returned device performed as intended per the mynxgrip instructions for use.Dimensional analysis was attempted; however, it was not possible to obtain an accurate measurement as the device showed evidence of a provoked segmentation in the distal portion of the black shuttle.Per microscopic analysis scratch marks were observed in the segmentation borders.These types of scratch marks are commonly attributed to surface interaction with sharp edges materials.Visual inspection at high magnification showed that the sealant was not present in manufacturing position.The reported ¿sealant failure to achieve hemostasis¿ was not confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined.Patient factors, pharmacological factors and/or handling factors of the device may have contributed to the reported event.Failing to achieve hemostasis immediately after vascular closure after a catheterization procedure are a common procedural complication and are listed in the product¿s instructions for use (ifu) as such.This event is frequently related to stick technique, anticoagulation, blood pressure, adequate sheath/device removal technique and the patient's compliance to decrease mobility of the limb affected in order to promote coagulation.Neither the event description nor the product analysis suggests that the reported event could be related to the 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
• MDR Report Key: 17887053
• MDR Text Key: 325260896
• Report Number: 3004939290-2023-03406
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX5021
• Device Lot Number: F2229806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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