MAUDE Adverse Event Report: EDWARDS EDWARDS; SWAN-GANZ VIP CATHETER

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 12/30/2015

Event Type  Injury  

Event Description

The rn went to inflate the balloon on the swan to obtain a paop (wedge) pressure as per routine.Normally the waveform changes.The waveform did not change.The rn tried to allow the balloon to passively deflate as per routine.No air came back into the syringe.The nurse was appropriately alarmed, and realized that meant the air had escaped the balloon and was in the patient's pulmonary artery.The rn alerted the cardiology fellow who agreed that the balloon was likely ruptured, and they discontinued the swan-ganz catheter.The patient was asymptomatic despite 1.5 cc air bolus into his pulmonary artery.Upon inspection after removal, the balloon on the catheter did have a tiny hole in it.

• Brand Name: EDWARDS
• Type of Device: SWAN-GANZ VIP CATHETER
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 5584295
• MDR Text Key: 42960312
• Report Number: MW5061746
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 77