MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ CCO; THERMODILUTION CATHETER

Model Number 139HF75P

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 07/12/2016

Event Type  malfunction  

Event Description

Upon attempting to remove the swan-ganz catheter, there was some resistance and the catheter broke with a portion of the catheter remaining in the patient.Cxr showed the portion of the catheter in the ijv, svc, ra and the tip was in the rv.Patient was taken to the cath lab and removed my snaring it.

• Brand Name: SWAN-GANZ CCO
• Type of Device: THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 5829847
• MDR Text Key: 50746380
• Report Number: MW5063694
• Device Sequence Number: 1
• Product Code: DYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2016
• Device Model Number: 139HF75P
• Device Lot Number: 60044938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 99