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

Model Number	C146F7
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease (cad), hypertension (htn) and atrial fibrillation (a fib).Procedure: heart cath for transcatheter aortic valve replacement (tavr) evaluation.While having the heart cath, the balloon of the latex free swan ruptured.Device removed and another one used.Minor delay in procedure, no known harm to the patient, discharged the same day.Please note that this is #12 latex free swans that have been reported from this facility.Manufacturer response for catheter, intravascular, diagnostic, swan-ganz controlcath (per site reporter): will obtain.

• 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: 13731827
• Report Number: 13731827
• Device Sequence Number: 17299149
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)231123(11)211123(10)64025025
• 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): 02/28/2022
• Report Date (Section F): 02/28/2022

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: 64025025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 02/28/2022