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

Catalog Number MX6760

Device Problems Decrease in Pressure (1490); Material Rupture (1546); Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) did not stop at the arteriotomy and the whole device was removed from the artery.Manual compression was used for 20 minutes to achieve hemostasis.The patient recovered.There was no reported patient injury.The device was inserted through an unknown short sheath into the artery.The device was used in an interventional procedure with a retrograde approach.A 6f non-cordis sheath was used.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 5 mm in diameter.There was no vessel tortuosity.The stick location was in the middle 1/3 of femoral head in the common femoral artery (cfa).There was no presence of pvd / calcium in the vicinity of the puncture site.The balloon was not tested outside patient but inflated inside patient under fluoroscopy.The device was purged of air during prep.There was no scar tissue present in the vicinity of the puncture site.Excessive tension was not applied to the device.There were two exchanges prior to the deployment sheath.The user is mynx certified.The balloon was inflated, and the stopcock was closed.The device was then pulled in backward motion and the device was removed from the arteriotomy as the balloon did not stop.The device will be returned for evaluation.

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.

Manufacturer Narrative

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) did not stop at the arteriotomy and the whole device was removed from the artery.Manual compression was used for 20 minutes to achieve hemostasis.The patient recovered.There was no reported patient injury.The device was inserted through an unknown short sheath into the artery.The device was used in an interventional procedure with a retrograde approach.A 6f non-cordis sheath was used.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 5 mm in diameter.There was no vessel tortuosity.The stick location was in the middle 1/3 of femoral head in the common femoral artery (cfa).There was no presence of pvd / calcium in the vicinity of the puncture site.The balloon was not tested outside patient but inflated inside patient under fluoroscopy.The device was purged of air during prep.There was no scar tissue present in the vicinity of the puncture site.Excessive tension was not applied to the device.There were two exchanges prior to the deployment sheath.The user is mynx certified.The balloon was inflated, and the stopcock was closed.The device was then pulled in backward motion and the device was removed from the arteriotomy as the balloon did not stop.A non-sterile ¿mynx control vcd 6f/7f¿ was returned for evaluation.Visual inspection showed button 1 was fully depressed and button 2 was not depressed.The syringe was received connected to the device with the stopcock closed.The sealant was not returned for evaluation.The balloon was received fully deflated, and an unknown procedure sheath was locked on to the sheath catch.Blood was noted on the procedure sheath with no damages noted.A leak in the balloon was identified during a leak test therefore, an inflation/deflation test was not performed.Visual inspection at high magnification revealed a longitudinal tear in the balloon.The malfunction ¿mynx control balloon-balloon loss of pressure¿ was confirmed.The exact cause of the reported event could not be conclusively determined.This type of tear is typically observed when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft).Due to the nature of the complaint, the reported, ¿balloon- pull through¿ could not be confirmed.However, the torn balloon likely contributed to the event.According to the instructions for use, which is not intended as a mitigation of risk, users are instructed not to use the device if the balloon does not maintain pressure.Based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective 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: 18322847
• MDR Text Key: 330467854
• Report Number: 3004939290-2023-03529
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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,Followup
• Report Date: 02/22/2024

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: MX6760
• Device Lot Number: F2330502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• 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: 6F TERUMO PINNACLE.