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

Catalog Number MX5021

Device Problems Defective Component (2292); Separation Failure (2547)

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

Event Type  malfunction  

Manufacturer Narrative

Please note that the date of this procedure is unknown.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, there was insufficient hemostasis during the use of a 5f mynxgrip vascular closure device (vcd).There were no reported injuries to the patient.Additional information was requested but was unavailable.The device will be returned for evaluation.

Event Description

As reported, there was insufficient hemostasis during the use of a 5f mynxgrip vascular closure device (vcd).There were no reported injuries to the patient.Additional information was requested but was unavailable.The device will be returned for evaluation.Addendum: product evaluation revealed that the sealant was adhered to the device components.

Manufacturer Narrative

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.H3 other text : 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d9, g3, g6, h1, h2, h3, h6, and h10 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 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, there was insufficient hemostasis during the use of a 5f mynxgrip vascular closure device (vcd).There were no reported injuries to the patient.Additional information was requested but was unavailable.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 syringe was connected to the device with the stopcock opened.The advancer tube was on the catheter, and the sealant was exposed to blood, adhering to the catheter shaft as received.In addition, an unknown procedural sheath was on the device, exposed to blood.Dimensional analysis was performed to verify the distance between the shuttle tip to the inflated balloon, and dimensional analysis results were found with the specification.Per functional analysis, in order to test the device, the sealant was removed from the catheter shaft.After the removal of the sealant, the shuttle was advanced completely without issue, and the advancer tube was proximally retracted and found properly engaged to proximal tamp lock as intended per the mynxgrip instructions for use (ifu) during the failure investigation.Per microscopic analysis, visual inspection at high magnification showed the presence of a slit in the outer cartridge.In addition, the sealant was exposed to blood, adhering to the catheter shaft.The reported event of ¿sealant failure to achieve hemostasis¿ was confirmed through analysis of the returned device since the sealant was still on the catheter, showing a ¿sealant-stuck to device components¿ condition.However, the exact cause of the issue experienced could not be conclusively determined during analysis.Based on the limited information available for review, it is difficult to determine what factors may have contributed to the sealant becoming stuck to the shuttle after sealant deployment.However, as the advancer tube was still on the catheter, indicating that an incomplete removal of the device occurred, the issue may have been attributed to incorrectly following the ifu.Per the mynxgrip ifu, which is not intended as a mitigation, step 3: remove device instructs users to ensure complete balloon deflation, then slowly withdraw the balloon catheter through the advancer tube lumen.Failure to hold the advancer tube in place and/or a proper position of the tamping tube was not maintained during catheter removal, the sealant could be dislodged from the vessel wall, resulting in the reported incident.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/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, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 17797833
• MDR Text Key: 324017485
• Report Number: 3004939290-2023-03376
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)250228(10)F2304501
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX5021
• Device Lot Number: F2304501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• 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: UNK.