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

Model Number	C146F7
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 12623165
• Report Number: 12623165
• Device Sequence Number: 19656356
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230803(11)210803(10)63909479
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2021
• Report Date (Section F): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63909479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/30/2021