MAUDE Adverse Event Report: CORDIS US CORP. DX CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UNKDIAGC

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

As reported, during a cardiomems implant procedure, following the initial insertion of the pulmonary wedge catheter, the physician determined that it would be necessary to change out the catheter to select a target vessel.The pulmonary artery (pa) catheter was removed, and a new unknown catheter was advanced through the right ventricle.At this time, it was noted that the patient was becoming bradycardic, and medications were given as a result.The implant procedure was completed.Additional medications were administered post procedure and the patient was admitted for observation due to continued bradycardia and hypotension.The physician reports the cause of the bradycardia was the advancement of the unknown judkins right (jr) cordis catheter.An unknown sv5 cordis guidewire was also used for the procedure.Without the return of the unknown jr cordis catheter or the sv5 wire for analysis, it cannot be confirmed if the adverse events of bradycardia and hypotension were related to device malfunctions and the exact cause cannot be determined.Contact between the heart tissue and the devices is a likely cause of these adverse events.Users are trained to inspect for signs of damage prior to and during use.Any product 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, ¿catheters- complications may occur at any time during or after the procedure.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.Sv5- possible complications include, but are not limited to air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.¿ based on the information available, 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, during a cardiomems implant procedure, following the initial insertion of the pulmonary wedge catheter, the physician determined that it would be necessary to change out the catheter to select a target vessel.The pulmonary artery (pa) catheter was removed, and a new unknown catheter was advanced through the right ventricle.At this time, it was noted that the patient was becoming bradycardic, and medications were given as a result.The implant procedure was completed.Additional medications were administered post procedure and the patient was admitted for observation due to continued bradycardia and hypotension.The physician reports the cause of the bradycardia was the advancement of the unknown judkins right (jr) cordis catheter.An unknown sv5 cordis guidewire was also used for the procedure.This information is sourced from a medwatch report.Additional information was not provided.The devices will not be returned for evaluation.

• Brand Name: DX CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18120072
• MDR Text Key: 327934009
• Report Number: 9616099-2023-06629
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKDIAGC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• 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: NON-ABBOTT CATHETER (JR 4 CORDIS),; SV5 GUIDEWIRE, AGILITY STEERABLE GUIDEWIRE
• Patient Outcome(s): Other