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

Model Number 096F6

Device Problem Incorrect Measurement (1383)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

One 096f6 catheter with 1ml syringe was returned for evaluation.The reported issue of would not obtain pressures correctly was unable to be confirmed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric with the returned syringe and remained inflated for five minutes.All through lumens passed the pressure test.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that during use of this swan-ganz catheter, while monitoring a patient, it was not possible to obtain pressures correctly.A new catheter was used, and everything worked fine.Troubleshooting included adjusting the transducer.The lot number is unknown.The device is available for return.There was no patient injury.

• Brand Name: SWAN-GANZ TRUE SIZE 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: 15303378
• MDR Text Key: 305370388
• Report Number: 2015691-2022-07539
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 096F6
• Device Catalogue Number: 096F6P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• 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