MAUDE Adverse Event Report: TELEFLEX NORTH AMERICA ARROW BALLOON WEDGE-PRESSURE CATHETER

Catalog Number 60801902002879

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/25/2023

Event Type  Death  

Event Description

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.

• Brand Name: ARROW BALLOON WEDGE-PRESSURE CATHETER
• Type of Device: ARROW BALLOON WEDGE-PRESSURE CATHETER
• Manufacturer (Section D): TELEFLEX NORTH AMERICA; morrisville NC
• MDR Report Key: 17558613
• MDR Text Key: 321283529
• Report Number: 17558613
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2023,08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60801902002879
• Device Lot Number: 16F23D0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2023
• Distributor Facility Aware Date: 07/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American