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

Model Number C146F7

Device Problem Material Rupture (1546)

Patient Problem Dyspnea (1816)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Elderly female with history of hypertension and coronary artery disease.Admitted with increased shortness of breath.While having a cardiac catheterization, the edwards swan balloon ruptured while in the patient.No known harm to patient, product removed, and new device used.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11398437
• MDR Text Key: 234231938
• Report Number: 11398437
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)220921(11)200921(10)63386822
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63386822
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Weight: 59