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 Pneumothorax (2012)

Event Date 12/05/2016

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 model and lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Pneumothorax is a known potential complication of a swan ganz catheter insertion.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

It was reported that during an attempt to insert a swan ganz catheter via the right jugular vein, a pneumothorax occurred.It was noted that this was the site of a previous swan ganz.The catheter was inserted without checking if the catheter position was correct.Required treatment was ¿minor.¿ there were no patient consequences reported.The information was obtained from (b)(4).

• 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: 6191174
• MDR Text Key: 62909091
• Report Number: 2015691-2016-03832
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 12/05/2016

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: 12/05/2016
• Initial Date FDA Received: 12/20/2016
• 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: 40 YR