FDA Adverse Event Death Summary report: N

ARROW BALLOON WEDGE-PRESSURE CATHETER

MDR report key: 17558613 · Received August 16, 2023

Report

Report Number
17558613
Event Type
Death
Date Received
August 16, 2023
Date of Event
July 25, 2023
Report Date
August 2, 2023
Manufacturer
TELEFLEX NORTH AMERICA
Product Code
DYG
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY IN STABLE CONDITION. ALL RISK AND BENEFITS OF THE PROCEDURE WERE EXPLAINED TO THE PATIENT AND SHE EXPRESSED UNDERSTANDING. A RIGHT TRANS FEMORAL APPROACH WAS USED. THE RIGHT GROIN AREA WAS PREPARED AND DRAPED IN A STERILE FASHION AND THEN ANESTHETIZED USING 1% LIDOCAINE. WITH ULTRASOUND GUIDANCE, WE OBTAINED ACCESS TO THE RIGHT COMMON FEMORAL ARTERY AND VEIN WITH MICRO PUNDURE NEEDLE AND THEN ADVANCED A 6 FR SHEATH OVER A WIRE IN EACH USING THE SELDINGER APPROACH. ARROW CATHETER WAS ADVANCED IN THE PULMONARY ARTERY AND USED TO OBTAIN HEMODYNAMICS MEASUREMENTS. DURING CATHETER ADVANCEMENT OVER A J-WIRE TO OBTAIN ACCURATE PULMONARY WEDGE PRESSURE, PATIENT DECOMPENSATED AND WENT INTO RESPIRATORY ARREST WITH HEMOPTYSIS AND ASPIRATION. THIS COULD HAVE BEEN SECONDARY TO POSSIBLE CATHETER INDUCED PULMONARY ARTERY RUPTURE AND PULMONARY HEMORRHAGE. DESPITE ALL EMERGENT CARDIOPULMONARY RESUSCITATION EFFORTS PATIENT EXPIRED. AN 84 YO FEMALE WITH HISTORY OF HTN, HLP, HFPEF, MODERATE VALVULAR DISEASE AND COPD/OSA ADMITTED FOR CHEST PAIN AND SOB. PRIOR HISTORY OF CARDIAC CATHETERIZATION IN 2021, WITH MILD DISEASE AND ECHO IN 2021 SHOWED AS AND AL. REPEAT ECHO IN 6/23 SHOWED PRESERVED EF AND MODERATE AS. SHE WAS SCHEDULED FOR OP PROCEDURE BUT HER SYMPTOMS GOT WORSE WARRANTING HER TO COME TO THE EMERGENCY DEPARTMENT. EKG SHOWED SINUS BRADYCARDIA WITH T-WAVE INVERSION. HS TRAP 52-49-52, PRO BNP 7183. CXR SHOWS CARDIOMEGALY AND MILDLY PULMONARY EDEMA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
491384 ARROW BALLOON WEDGE-PRESSURE CATHETER ARROW BALLOON WEDGE-PRESSURE CATHETER DYG TELEFLEX NORTH AMERICA 16F23D0043

Patients

Seq Age Sex Outcome Treatment
1 84 YR Female Death