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

Catalog Number MX6760E

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

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

Event Date 12/03/2023

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 6/7f mynx control vascular closure (vcd) ruptured when the user attempted to inflate it.No patient injuries were reported, and hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.The device was used during percutaneous coronary intervention (pci) using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the unknown vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.The device was prepared according to the instructions for use.The device was opened in a sterile field.The device was prepped and stored per the instructions for use (ifu).A 6f non-cordis sheath was used.The balloon lost pressure during patient use.There was no prior pta, stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath after removal.There was no visible damage in distal end of the sheath after removal.There was no presence of pvd / calcium in the vicinity of the puncture site.There was little vessel tortuosity.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a 6f/7f mynx control vascular closure (vcd) ruptured when the user attempted to inflate it.No patient injuries were reported, and hemostasis was achieved with manual compression for 25 minutes, resulting in no extended hospitalization.The device was used during percutaneous coronary intervention (pci) using a retrograde approach, and the physician was being trained on its use.The suitability of the femoral artery was verified on angiography, including the insertion angle (30-45 degrees) of the unknown vascular sheath introducer, as per the instructions for use (ifu).The vessel type was femoral arterial, and its diameter was verified to be greater than 5 mm.The device was stored and prepared according to the ifu.The device was opened in a sterile field.A 6f non-cordis sheath was used.The balloon lost pressure during patient use.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.There was no visible damage to the sheath or distal end of the sheath after removal.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.There was little vessel tortuosity.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 6f/7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed, and the stopcock was observed opened.The syringe and procedural sheath were not received for evaluation.The balloon was found fully deflated.In addition, the sealant was found in its manufactured position fully covered by the sealant sleeves and exposed to blood.Per functional analysis, an inflation/deflation test was performed per the mynx control ifu.The results revealed a leak in the balloon of the returned device.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the returned device and the sealant was found in its manufactured position fully covered by the sealant sleeves and exposed to blood.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, it is difficult to determine what factors may have contributed to the loss of pressure reported.However, access site vessel characteristics (although reported to have no pvd/calcium within the vicinity of the puncture site) and/or concomitant device factors (although reported that the procedural sheath had no visible damages noted) most likely contributed to the reported event since a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause this type of damage to the balloon.According to the ifu, which is not intended as a mitigation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, the ifu instructs 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: MYNX CONTROL
• 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: 18426208
• MDR Text Key: 331932330
• Report Number: 3004939290-2024-00005
• 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
• Report Date: 03/11/2024

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: MX6760E
• Device Lot Number: F2229922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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
• Treatment: UNKNOWN SHEATH
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian