MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 746F8

Device Problem Use of Device Problem (1670)

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

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Lot number was not provided; therefore, review of the manufacturing records could not be 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 part of this monthly review.

Event Description

It was reported that the catheter could not be removed during use.The catheter was sewn-in somewhere from between the proximal injectate port and the thermal filament, but the exact location is unknown since the device was discarded.The customer was preparing for thoracotomy procedure in order to remove the catheter, but the catheter was able to be removed by pulling the catheter under radiographic guidance, thus no surgical intervention was required.The customer does not normally use radiographic guidance as part of catheter removal process.Further detail and the circumstances of how the catheter was removed could not be obtained.No inaccurate value or leakage were observed during use.No additional procedure such as new insertion site was required.There were no patient complications reported after the catheter removal.The customer considered that the difficulty of the catheter removal occurred due to the catheter sewn-in since they felt resistance when attempting to remove the catheter, and therefore it is not related to the device malfunction.The actual occurrence date is unknown.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12167436
• MDR Text Key: 265671332
• Report Number: 2015691-2021-04091
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention