MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/12/2023

Event Type  Injury  

Event Description

As reported, a 6f mynx control vascular closure device was inserted into a cordis avanti 6f catheter sheath introducer (csi).The balloon was inflated until the black marker was fully visible, white black white.After positioning of the balloon according to tension indicator and under fluoroscopy, the plug was released by pushing button number one.It was noticed that the black marker for the pressure gauge was no longer visible.After removal of the device and one minute fingertip compression, hemostasis was not achieved, and manual compression was needed to close.The plug was not visible on the device.Approximately thirty minutes after the procedure, the patient came back due to pain in the leg.It is unknown where in the leg the pain was being experienced.A crossover angiogram was performed after the pain was reported but the results were not provided.The patient is still hospitalized and under observation as of six days after the event.The reason for the pain is still unknown.The user is in training on the use of the device and this was the second case performed, with the sales representative present.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 and moderate presence of pvd / calcium in the vicinity of the puncture site, as shown on fluoroscopy.The tension indicator was aligned with the markers on the side before attempting to deploy.The catheter was stabilized and tension held with the user's left hand.The mynx will be returned for evaluation.The sheath will not be returned for evaluation.

Manufacturer Narrative

This report is related to report #3004939290-2023-03418.This device is reported to not be available for analysis and no device has been received at the time of this report.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 6f mynx control vascular closure device was inserted into a cordis avanti 6f catheter sheath introducer (csi).The balloon was inflated until the black marker was fully visible, white black white.After positioning of the balloon according to tension indicator and under fluoroscopy, the plug was released by pushing button number one.It was noticed that the black marker for the pressure gauge was no longer visible.After removal of the device and one minute fingertip compression, hemostasis was not achieved, and manual compression was needed to close.The plug was not visible on the device.Approximately thirty minutes after the procedure, the patient came back due to pain in the leg.It is unknown where in the leg the pain was being experienced.A crossover angiogram was performed after the pain was reported but the results were not provided.The patient is still hospitalized and under observation as of six days after the event.The reason for the pain is still unknown.The user is in training on the use of the device and this was the second case performed, with the sales representative present.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 and moderate presence of pvd / calcium in the vicinity of the puncture site, as shown on fluoroscopy.The tension indicator was aligned with the markers on the side before attempting to deploy.The catheter was stabilized and tension held with the user's left hand.The mynx will be returned for evaluation.The sheath was not expected to be returned for evaluation, but later was returned with the sheath, as demonstrated by product analysis of mynx device.

Manufacturer Narrative

This report is related to report 3004939290-2023-03418.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

This report is related to report: #3004939290-2023-03418.Complaint conclusion: as reported, a 6f/7f mynx control vascular closure device (vcd) was inserted into a cordis avanti 6f catheter sheath introducer (csi), and the balloon was inflated until the black marker was fully visible, white-black-white.After positioning of the balloon according to the tension indicator and under fluoroscopy, the plug was released by pushing button number one.It was noticed that the black marker for the pressure gauge was no longer visible.After removal of the device and one minute fingertip compression, hemostasis was not achieved, and manual compression was needed to close.The plug was not visible on the device.Approximately thirty minutes after the procedure, the patient came back due to pain in the leg.It is unknown where in the leg the pain was being experienced.A crossover angiogram was performed after the pain was reported but the results were not provided.The patient is still hospitalized and under observation as of six days after the event.The reason for the pain is still unknown.The user was in training on the use of the device, and this was the second case performed, with the sales representative present.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 no vessel tortuosity and moderate presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site, as shown on fluoroscopy.The tension indicator was aligned with the markers on the side before attempting to deploy.The catheter was stabilized, and tension was held with the user's left hand.A non-sterile ¿csi avanti+.035 f6 w/mini gw¿ was received for product investigation locked onto the sheath catch of the mynx control vcd 6f/7f.Per visual analysis, the procedural sheath device was inspected for anomalies which may have contributed to the reported incident; however, no anomalies were observed.In addition, blood was noted in the procedural sheath.Per functional analysis, a simulated insertion/withdrawal test was performed on the returned device.No resistance was felt when the device reinserting into the returned sheath.The reported event of ¿pressure gauge-inflation indicator extension difficulty¿ was not confirmed through analysis of the returned mynx control device as there were no anomalies noted during functional analysis with the inflation indicator and balloon.Additionally, the reported event of ¿sealant-inability to achieve hemostasis¿ was not confirmed since the sealant was not included with the device and due to the nature of the complaint.The exact issues experienced by the customer could not be conclusively determined during analysis.Pain is an unpleasant physical discomfort or sensation experienced by the patient.However, pain is subjective to the patient, and there are many potential causes to the pain reported.Without further information on the condition of the puncture site and the reason for the pain and hospitalization extension, it is not possible to determine what factors may have contributed to the incidents reported.Additionally, discomfort at the access site is an expected and foreseeable experience after a catheterization due to the intended penetrating injury to the artery, which includes the initial puncture, insertion of the sheath introducer, and use of a vascular closure device.The complaints of ¿pain¿ and ¿hospitalization¿ could not be confirmed, and no determinations of possible contributing factors could be made.Based on the information available for review and product analyses, it is difficult to determine what factors may have contributed to the mynx control device failures reported, especially since there were no anomalies noted to the devices.However, as the balloon was not fully retracted/button 2 was not fully depressed, it is possible this condition could have resulted in the inability to achieve hemostasis event reported.Additionally, procedural/handling factors (user was in training) likely contributed to the inflation indicator issue reported since there were no anomalies with the product.According to the instructions for use (ifu), which is not intended as a mitigation, ¿step 1: position balloon: insert the mynx control vcd into the procedural sheath through the sheath valve.Advance the catheter until the sheath catch nears the hub of the sheath.Rotate the sheath catch as needed to hook onto the side port of the procedural sheath.Orient the device such that the tension indicator window on the handle assembly is facing upwards.Inflate the balloon until the black marker is fully visible on the inflation indicator and close stopcock.¿ the ifu also instructs, ¿step 3: remove device: retract the syringe plunger to lock position.Apply light fingertip compression proximal to the insertion site and then lightly grasp the device at skin with thumb and forefinger and realign with the tissue tract.Open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.Pick up the device handle and realign with the tissue tract.Depress button #2 to pull the deflated balloon into the device.While maintaining fingertip compression on the skin, remove the device from the patient.Continue to apply fingertip compression for up to 1 minute or as needed.¿ if the device is removed before completing balloon deflation, or if proper position of the device is not maintained during the catheter removal, the sealant could be dislodged from the vessel wall.Neither the product analyses, nor the information available for review suggest that the reported failures and issues could be related to the design or manufacturing process of the units.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: AVANTI
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17919225
• MDR Text Key: 325478359
• Report Number: 9616099-2023-06607
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032000628
• UDI-Public: 10705032000628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970392
• 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: 03/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 402606X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 03/02/2024
• Supplement Dates FDA Received: 02/08/2024; 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: MYNX CONTROL.
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White