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

Model Number 131F7

Device Problems Unable to Obtain Readings (1516); Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Event Description

Swan catheter would not draw back blood or give pressure readings.Swan catheter was switched out to another 7 fr swan catheter which was giving the same problem.Both catheters were inspected outside the body and had issues with resistance and drawing both air and fluid.5 fr catheter was then inserted and worked without issue.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10270231
• MDR Text Key: 198700797
• Report Number: 10270231
• Device Sequence Number: 1
• Product Code: DYG
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 220120
• 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: 06/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 94