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

Catalog Number MX5021

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

As reported, a 5f mynxgrip vascular closure device (vcd) popped in the patient vessel.A second 5f mynxgrip was opened and closure with the other 5f mynxgrip was successful.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The device was used in an angiogram with a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was moderate peripheral vascular disease/ calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The balloon lost pressure immediately.There was no visible damage to the distal end of the sheath after removal.The device is being returned for evaluation.

Manufacturer Narrative

As reported, a 5f mynxgrip vascular closure device (vcd) popped in the patient vessel.A second 5f mynxgrip was opened and closure with the other 5f mynxgrip was successful.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The device was used in an angiogram with a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was moderate peripheral vascular disease/ calcium in the vicinity of the puncture site.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The balloon lost pressure immediately.There was no visible damage to the distal end of the sheath after removal.A non-sterile ¿mynxgrip vascular closure device 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the shuttle was engaged to the black handle and the stopcock was found opened.The syringe and the procedural sheath were not returned with the device.The sealant and advancer tube were observed on the catheter shaft.In addition, the balloon was found fully deflated.Per functional analysis, leak testing was performed on the balloon of the returned device per the mynxgrip ifu.The results revealed a leak in the balloon.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (there was moderate peripheral vascular disease/ calcium in the vicinity of the puncture site) and/or concomitant device factors (although not returned and reported with no visible damage to the distal end of the sheath after removal) likely resulted in the rupture reported since calcification at the access site and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon.According to the ifu, which is not intended as a mitigation, ¿the safety and effectiveness of mynxgrip 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.There is no evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu instructs users to discard the device if the balloon does not maintain pressure.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 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: 19190710
• MDR Text Key: 341577067
• Report Number: 3004939290-2024-00207
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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: F2327203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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