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

Catalog Number MX5021

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 11/22/2023

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, the balloon of a 5f mynxgrip vascular closure device (vcd) ruptured during the procedure while inside of the patient.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 5f non-cordis 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 moderate presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in diagnostic procedure with a retrograde approach.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

Complaint conclusion: as reported, the balloon of a 5f mynxgrip vascular closure device (vcd) ruptured during the procedure while inside of the patient.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 5f non-cordis 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 moderate presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in diagnostic procedure with a retrograde approach.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.The product was returned for analysis.A non-sterile 5f mynx grip vascular closure device involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle.The sheath used in the procedure were not returned with the device for the evaluation, nevertheless the syringe was observed attached to the returned unit with the stopcock open.The sealant was observed to be protruded attached to the distal catheter body and the advancer tube was in manufacturing position.Functional testing was executed using the returned syringe and the cordis lab syringe, during this analysis it was noted that a balloon leak was present in the received unit related to an observed longitudinal tear.A microscopic analysis was performed in the balloon to confirm the state of the surface and body.During the analysis was observed that a longitudinal tear was present in the balloon¿s surface.This tear was concluded to be attributable to the balloon loss of pressure reported.The reported ¿balloon loss of pressure¿ was confirmed during analysis of the returned device as a longitudinal tear was observed during microscopic analysis.However, the exact cause of the reported event could not be conclusively determined.This type of tear is typically observed when the balloon encounters calcification and/or other procedural devices.It was reported there was moderate presence of calcium in the vicinity of the puncture site.Based on the information available for review, access site vessel characteristics (presence of pvd/calcium in the vicinity of the puncture site with little tortuosity) most likely contributed to the loss of pressure reported since calcification/pvd at the access site can cause damage to the balloon, resulting in a loss of pressure.According to the mynxgrip ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynxgrip vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram or venogram: common femoral artery or vein single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Based on the information provided, there is no indication the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Manufacturer Narrative

After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• 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: 18372388
• MDR Text Key: 331339168
• Report Number: 3004939290-2023-03543
• 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
• Report Date: 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F2320703
• 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
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/13/2024; 08/01/2024
• Supplement Dates FDA Received: 02/21/2024; 08/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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 SHEATH