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 Perforation of Vessels (2135)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.

Event Description

Information was obtained from the (b)(6).It was reported that a (b)(6) patient with severe mitral incompetence was undergoing a mitral valve replacement with an advanced cco swan ganz catheter in place.Surgery was performed without incident.After surgery, heavy bleeding from the trachea was noted.Patient was suctioned and hemodynamic values were stable.Patient was moved to icu.After transfer, blood gas measurement was noted to have oxygenation reduction.Percutaneous cardiopulmonary support device was initiated.Ct was performed where bleeding from the left pulmonary artery was noted.Interventional radiology performed a coiling of the central pulmonary artery.Cause of pulmonary artery injury is unknown.The outcome of the patient is not known as no further information was available.

• Brand Name: SWAN GANZ CATHETER
• 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 ; 9497564386
• MDR Report Key: 5908782
• MDR Text Key: 53275455
• Report Number: 2015691-2016-02618
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 08/02/2016

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: 08/02/2016
• Initial Date FDA Received: 08/26/2016
• 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 Age: 80 YR