MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VENOUS PULMONARY ARTERY CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 096F6

Device Problems Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, this patient underwent a right heart catheterization via right internal jugular (ij) vein.After successfully completing the superior vena cava (svc) portion of the procedure, the venous pulmonary artery catheter was pulled back.On the way of advancing the catheter to the inferior vena cave (ivc) the balloon was inflated and the md saw air and noticed the balloon deflated.The catheter was pulled back and withdrawn.Outside the body, upon visual inspection, it was noted that the balloon material was intact on the swan, however when inflation was attempted, the balloon inflated partially and blood/air was expelled with a leak noted.No harm to the patient and he was later brought back to his inpatient room in stable condition.Fda safety report id # (b)(4).

• Brand Name: SWAN-GANZ VENOUS PULMONARY ARTERY CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 12261150
• MDR Text Key: 264853826
• Report Number: MW5102922
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 096F6
• Device Lot Number: 63686200
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 75