MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC. SWAN-GANZ CCO; CATHETER, CONTINUOUS FLUSH

Catalog Number 139HF75P

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The physician had difficulty advancing the swan-ganz catheter and on removal of the catheter noted that the top part had sheared off and was missing.The patient required an additional procedure for removal.

• Brand Name: SWAN-GANZ CCO
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC.; one edwards way; irvine CA 92614 568
• MDR Report Key: 4454539
• MDR Text Key: 16182482
• Report Number: 4454539
• Device Sequence Number: 1
• Product Code: KRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 139HF75P
• Device Lot Number: 59860935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2015
• Patient Sequence Number: 1
• Patient Age: 71 YR