MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW DOUBLE-LUMEN BALLOON WEDGE PRESSURE CATHETER; CATHETER, FLOW DIRECTED

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 11/16/2023

Event Type  Injury  

Event Description

During the right heart catheterization portion of the cardiomems implant procedure, prior to any cardiomems equipment being opened or used, the patient had a bradycardiac arrest.This happened when the physician attempted to advance the arrow balloon wedge pressure catheter from the right atrium to the right ventricle.Cardiomems implantation was aborted.The patient received atropine and compressions, and was externally paced following the event.It was noted the patient has a baseline right bundle branch block.Patient is stable and discharged.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ARROW DOUBLE-LUMEN BALLOON WEDGE PRESSURE CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 18358585
• MDR Text Key: 331048117
• Report Number: MW5149381
• Device Sequence Number: 1
• Product Code: DYG
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1