MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR; SWAN-GANZ CATHETER

Model Number SWAN GANZ UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Date 04/22/2015

Event Type  Death  

Event Description

It was reported that a patient had surgery for an acute aortic dissection.After being transferred to the icu, the patient was soon thereafter taken back to the or for a re-thoracotomy hemostatis.Upon completion of the second surgery, the patient was transfer from the or table to the patient¿s bed.During this transfer, the pulmonary artery catheter was inadvertently pulled back by the or staff.Liquid was seen inside the contamination shield and was determined to be a vasopressor drug that was being administered to the patient via the pa catheter.The catheter was attempted to be re-advanced by the anesthesiologist, but due to the patient¿s unstable clinical status, transfer to the icu was prioritized.The patient later expired due to post-surgery complications unrelated to the pa catheter.

Manufacturer Narrative

The device was not available for return.No model or lot number was able to be obtained.Without the return of the product, it is not possible to determine if damages or defects existed on the product.No actions will be taken at this time.

• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 4775483
• MDR Text Key: 20719769
• Report Number: 2015691-2015-01131
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 05/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death