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

Catalog Number 402605X

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

This report is related to medwatch report # 3004939290-2023-03541.Complaint conclusion: as reported, after use of a 5f mynxgrip vascular closure device (vcd) and a 5f avanti+ introducer sheath the patient developed a bacterial infection in the puncture site.The entire hospitalization was six days.Hemostasis was achieved with the mynx device.The device deployed as expected.The device packaging was not compromised during storage.The packaging was opened in a sterile field and sterile technique was followed.The puncture site was sterilized prior to the procedure with a sterile antiseptic solution.The patient stayed in the hospital for five days after the infection was found.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 5f cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The patient received prophylactic antibiotics prior to the procedure.The patient was under local anesthesia during the procedure.The procedure was performed as inpatient.The access site was cleaned/maintained post-procedure with a bandage with sterile gauze.The patient was not immunocompromised or had experienced a recent infection.The patient was not a smoker.The patient was not taking chemotherapy, steroid therapy, or tnf inhibitors.The mynx vcd was used in interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices were thrown out before the puncture site became infected; therefore, they will not be returned for evaluation.Without the return of the devices for analysis or images for review, it is not possible to determine if the reported adverse event ¿infection¿ is related to the manufacturing process for either device.Procedural/handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product or packaging with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿the mynxgrip vascular closure device is supplied sterile.Do not use if mynxgrip components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.(mynxgrip)¿ and ¿sterile.Sterilized with ethylene oxide gas.Nonpyrogenic.Radiopaque.For one use only.Do not resterilize.Remove csi from package using sterile technique.Possible complications include, but are not limited to air embolism, infection, intimal tear, hematoma, perforation of the vessel wall, thrombus formation (avanti).¿ 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.

Event Description

As reported, after use of a 5f mynxgrip vascular closure device (vcd) and a 5f avanti+ introducer sheath the patient developed a bacterial infection in the puncture site.The entire hospitalization was six days.Hemostasis was achieved with the mynx device.The device deployed as expected.The device packaging was not compromised during storage.The packaging was opened in a sterile field and sterile technique was followed.The puncture site was sterilized prior to the procedure with a sterile antiseptic solution.The patient stayed in the hospital for five days after the infection was found.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 5f cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The patient received prophylactic antibiotics prior to the procedure.The patient was under local anesthesia during the procedure.The procedure was performed as inpatient.The access site was cleaned/maintained post-procedure with a bandage with sterile gauze.The patient was not immunocompromised or had experienced a recent infection.The patient was not a smoker.The patient was not taking chemotherapy, steroid therapy, or tnf inhibitors.The mynx vcd was used in interventional procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices were thrown out before the puncture site became infected; therefore, it will not be returned for evaluation.

• Brand Name: AVANTI
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP; 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18571396
• MDR Text Key: 333608463
• Report Number: 9616099-2024-00029
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032000574
• UDI-Public: 10705032000574
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

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 Catalogue Number: 402605X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MYNXGRIP, 5F AVANTI+ INTRODUCER 402605X
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 70 KG