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

Model Number 131F7J

Device Problem Material Fragmentation (1261)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that saline leakage was observed from the catheter body during priming before use.Further information regarding the detailed location of the leak was unavailable.There were no patient complications reported.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of an evaluation.A supplemental report will be forthcoming when the investigation and device history results are completed.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.

Manufacturer Narrative

Our product evaluation lab received one model 131f7j swan-ganz catheter.The customer report of leakage was observed from the catheter body was confirmed.A cut/puncture of approximately 5mm in length was found on the catheter body at 38.5cm from the tip.The cut/puncture affected distal lumen.Edges of the cut/puncture did not appear to match up.No leakage was observed from the proximal injectate lumen.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.No visible damage was found from balloon.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.The appearance of this perforation on the catheter body is either cut or melted.The manufacturing process of the subassembly of the catheter was observed completely, including fixtures, high temperature machines, manufacturing process that involves scalpels or blades, location of the catheters between stations.There is no manufacturing process that involves high temperature or the use of a blade or scalpel in the location of the perforation.Based on the documentation and the information available, there is no evidence that indicates that the manufacturing procedures were not followed by the manufacturing personnel, therefore, a root cause could not be established.The ifu indicates instructions to verify lumens patency and balloon integrity prior catheter insertion: flush catheter lumens with a sterile solution to ensure patency and to remove air.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.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.

• Brand Name: SWAN-GANZ 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: 18804195
• MDR Text Key: 336623870
• Report Number: 2015691-2024-01434
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7J
• Device Lot Number: 65263103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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