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 11/09/2023

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.E1 reporter telephone number : (b)(6).

Event Description

As reported, while attempting to inject contrast and saline into the balloon of a 6/7f mynx control vascular closure device (vcd), there was a balloon rupture.The balloon lost pressure during the inflation step inside of the patient.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 a transfemoral cerebral angiogram 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 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 vcd was prepared according to the instructions for use.The device was used with a 6f non- cordis sheath.The device was stored according to the ifu.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.Additional patient and procedural details were requested but were not available.The device will be returned for evaluation.

Event Description

As reported, while attempting to inject contrast and saline into the balloon of a 6/7f mynx control vascular closure device (vcd), there was a balloon rupture.The balloon lost pressure during the inflation step inside of the patient.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 a transfemoral cerebral angiogram 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 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 vcd was prepared according to the instructions for use.The device was used with a 6f non- cordis sheath.The device was stored according to the ifu.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.Additional patient and procedural details were requested but were not available.The device was returned, however not received for evaluation.

Manufacturer Narrative

As reported, while attempting to inject contrast and saline into the balloon of a 6f/7f mynx control vascular closure device (vcd), there was a balloon rupture.The balloon lost pressure during the inflation step inside of the patient.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 a transfemoral cerebral angiogram 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 vascular sheath introducer, as per the instructions for use.The vessel type was femoral arterial, and its diameter was verified to be greater than 5mm.The vcd was prepared according to the instructions for use (ifu).The device was used with a 6f non-cordis sheath.The device was stored according to the ifu.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.Additional patient and procedural details were requested but were not available.The device was returned; however, not received for evaluation.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not received for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, access site vessel characteristics (lost pressure during inflation inside the patient) and/or concomitant device factors are possible since calcification at the access site or a frayed/damaged sheath tip can cause damage to the balloon, resulting in a loss of pressure.According to the mynx control ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control 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 prior to using the mynx control vcd: common femoral artery 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 available for review, there is no indication that the event is related to the design or manufacturing process of the unit.Therefore, no corrective/preventative action 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
• 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: 18301556
• MDR Text Key: 330172983
• Report Number: 3004939290-2023-03527
• 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: 03/14/2024

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: F2308204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2023
• 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: TERUMO 6F RADIOFOCUS SHEATH KIT
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian