MAUDE Adverse Event Report: CORDIS CORP. CORDIS 6F INFINITI ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SV5

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

Event Date 09/12/2023

Event Type  Other  

Event Description

During 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 pa(pulmonary artery) catheter was removed and a new catheter was advanced through the right ventricle.At this time, it was noted that the patient was becoming bradycardic.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 non-abbott catheter (jr 4 ¿ cordis).A sv5 guidewire was also used for the procedure.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5146911.

• Brand Name: CORDIS 6F INFINITI ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORP.
• MDR Report Key: 17930339
• MDR Text Key: 325819081
• Report Number: MW5146910
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/11/2023

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?: No
• Device Model Number: SV5
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• Patient Sequence Number: 1