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 Cardiac Perforation (2513)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported, during use, that bleeding from an unknown site in the lung was observed after a 7.5 fr swan-ganz catheter was inserted.The catheter was used for aortic valve replacement surgery and the bleeding was observed immediately after the surgery.The catheter is still placed in the patient and is unknown if the catheter will be returned.Further investigation will be performed to identify the site of bleeding and the patient status.Patient demographics requested but not obtained.

Manufacturer Narrative

Additional information was received that it was stated by the customer that the pulmonary artery was injured by the catheter as bleeding was noted from the lung after a bentall operation and ascending aortic arch replacement surgery.Hemostasis was achieved with interventional radiology on 09 march, 2018.The patient was recovering as of 30 march, 2018.The occurrence date was 2 march, 2018.The device was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The patient had aortic arch aneurysm.Non-edwards aortic valve was used for the surgery.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.Vascular complications, specifically pulmonary artery perforations, are listed as a potential complication in the product instructions for use (ifu).No description of the patient¿s anatomy was provided; therefore, it cannot be determined if significant tortuosity or tissue fragility was present.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.

• 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
• MDR Report Key: 7382269
• MDR Text Key: 103859963
• Report Number: 2015691-2018-01150
• 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,Followup
• Report Date: 03/13/2018

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: 03/13/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 61