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

Model Number SWAN GANZ UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it 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, nor could a root cause or potential contributing factors be identified.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.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).In this case, the patient experienced that the pulmonary artery catheter manipulation during the surgery induced massive intratracheal hemorrhage during aortic valve surgery.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

Information was obtained from the article pulmonary artery catheter-induced massive tracheal hemorrhage during aortic valve surgery: report of a case on kyobu geka.2020 sep;73(9):700-703.We report a case of pulmonary artery catheter (pac) -induced massive intratracheal hemorrhage during aortic valve surgery.An (b)(6)-year-old woman underwent aortic valve replacement and pulmonary vein isolation.Operative procedures were uneventful, but active and massive intratracheal hemorrhage started just after cardiopulmonary bypass was discontinued.We immediately resumed cardiopulmonary bypass and replaced the endotracheal tube with a double-lumen one, keeping the airway pressure high (20 cmh2o).Those maneuvers reduced intratracheal hemorrhage and maintained oxygenation, and then cardiopulmonary bypass was disconnected without lung lobectomy.Mechanical ventilation with high positive end expiratory pressure for 6 days in the intensive care unit led to her good recovery.A postoperative enhanced computed tomography revealed a thrombosed right pulmonary artery pseudoaneurysm possibly induced by pac.Patient status was stable at time of discharge.

• 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: 11318529
• MDR Text Key: 231612940
• Report Number: 2015691-2021-01233
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 54