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

Model Number C146F7

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

Patient with history of coronary heart disease, hypertension, recent chest pressure and shortness of breath was admitted for a right/left heart catheterization with angioplasty.The latex free swan balloon of the swan-ganz pulmonary artery catheter would not stay inflated.The swan-ganz pulmonary artery catheter was removed from patient without known harm, and a different one was used without problems.

• 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: 12452498
• MDR Text Key: 270842111
• Report Number: 12452498
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230312(11)210312(10)63662593
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 63662593
• 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: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 74