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

Model Number 831F75

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2023

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received on model 831f75 swan-ganz catheter.The customer report of balloon ruptured was confirmed.As received, balloon was found ruptured.Balloon edges did not appeared to match at the rupture.Inflation lumen and distal lumen were occluded with blood.All other through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body or syringe.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.The ifu states to check balloon integrity by inflating it to the recommended volume.Check for major asymmetry and for leaks by submerging in sterile saline or water.Deflate balloon before insertion.The ifu also states that the duration of catheterization should be the minimum required by the patients clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Event Description

It was reported that a swan ganz catheter had a suspected balloon rupture.The nurse said they noticed blood in the wedge syringe.This swan was placed by cath lab on 10/3.The suspected balloon rupture occurred on 10/14.There was no allegation of patient injury.Model number is 831f75.No troubleshooting was attempted.

• Brand Name: SWAN-GANZ FLOW DIRECTED THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW-DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco ; *
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco ; *
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18956155
• MDR Text Key: 338725578
• Report Number: 2015691-2024-02191
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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