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

Model Number	C146F7
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11398437
• Report Number: 11398437
• Device Sequence Number: 4760126
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)220921(11)200921(10)63386822
• 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): 02/25/2021
• Report Date (Section F): 02/25/2021

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: 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 02/25/2021