MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CONTROLCATH; CATHETER, FLOW DIRECTED

Model Number C146F7

Device Problem Material Rupture (1546)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

A patient with history of coronary artery disease, post st-elevation myocardial infarction (stemi) and stent placement was admitted due to recent chest pain and shortness of breath.Patient underwent a heart catheterization and the balloon, from the edwards lifesciences swan-ganz controlcath catheter, ruptured inside the patient.The balloon was removed intact without known harm.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12623165
• MDR Text Key: 276152187
• Report Number: 12623165
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230803(11)210803(10)63909479
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63909479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA