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

Model Number 141F7

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 01/08/2016

Event Type  malfunction  

Event Description

Five swan-ganz catheters clotted within the last week.This is unusual (per md).

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine, CA 92614
• MDR Report Key: 5366243
• MDR Text Key: 35944736
• Report Number: 5366243
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 141F7
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1