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

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

As reported, hemostasis was not achieved after a 5f mynxgrip vascular closure device (vcd) was removed from the patient's body.There was no reported patient injury.The device was stored, prepped, and used as per the instructions for use (ifu).The device was used in a transfemoral cerebral angiography (tace).There was no damage to the device prior to opening the package.The device will be returned for analysis.

Manufacturer Narrative

The product history review is expected but has not been completed.This device is reported to be available for analysis but has not been received at the time of this report.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: h10 the product history review is expected but has not been completed.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, hemostasis was not achieved after a 5f mynxgrip vascular closure device (vcd) was removed from the patient's body.The procedure was completed using manual compression.There was no reported patient injury.The device was stored, prepped, and used as per the instructions for use (ifu).The device was used in a transfemoral cerebral angiography (tace).There was no damage to the device prior to opening the package.The user was mynx certified.A 5f non cordis sheath was used.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 mild vessel tortuosity.The stick location was the common femoral artery.The device will be returned for analysis.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot f2304501 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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, hemostasis was not achieved after a 5f mynxgrip vascular closure device (vcd) was removed from the patient's body.The procedure was completed using manual compression.There was no reported patient injury.The device was stored, prepped, and used as per the instructions for use (ifu).The device was used in a transfemoral cerebral angiography (tace).There was no damage to the device prior to opening the package.The user was mynx certified.A 5f non cordis sheath was used.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 mild vessel tortuosity.The stick location was the common femoral artery.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 with the stopcock opened.The sealant, procedural sheath and advancer tube were not returned with the device.In addition, the balloon was observed fully deflated.The condition of the returned device is similar to a complete removal of the device.The device was inspected for anomalies which may have contributed to the reported incident and no anomalies were observed.Dimensional analysis was performed to verify the distance between the shuttle tip to the inflated balloon, and it was verified to be within specification.Since the condition of the returned device is similar to a complete removal of the device and the sealant/advancer tube of the returned device were not returned, no functional test could be performed on the returned device.Additionally, there were no visual non-conformities were observed to the returned device.Per microscopic analysis, visual inspection at high magnification showed the slit presence in the outer cartridge.A product history record (phr) review of lot f2304501 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.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 event reported since the device was returned in a condition that suggests the device was completely removed with no damages/anomalies noted.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 phr review, nor the product analysis 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 95054 ; 7863138372
• MDR Report Key: 17614482
• MDR Text Key: 321877726
• Report Number: 3004939290-2023-03324
• Device Sequence Number: 1
• Product Code: MGB
• 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,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: F2304501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• 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
• Treatment: 5F TERUMO.; UNK.