MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 131F7P

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Hemoptysis (1887)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures involve some patient risks.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.Blood clots have the potential to embolize to the pulmonary vasculature and cause embolism.In this event, the user stopped the procedure after seeing blood clots in multiple branches and administered anticoagulation therapy in the event that a blood clot travelled to the lungs.It is unknown whether user or procedural factors contributed to the stated event.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.

Event Description

It was reported that during a cardiomems implant procedure, while using a swan ganz catheter, via femoral access to pulmonary artery with a left entry.The physician was having a hard time aspirating the pa port.A wire was used to clear the swan ganz catheter.A pulmonary angiogram was done (normal part of procedure) to see the 3 main branches.At that time, clots were seen in vessel branches distal to catheter and the physician felt there was a pulmonary embolism.The procedure was stopped and anticoagulation therapy was started.The users do not administer heparin for this procedure as it may produce hemoptysis.Following anticoagulation therapy, there have been no reports of patient injury.No patient demographics received.

Manufacturer Narrative

Udi number: (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10248269
• MDR Text Key: 198091048
• Report Number: 2015691-2020-12446
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Model Number: 131F7P
• Device Lot Number: 62661517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention