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

Model Number 131F7J

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as device was discarded.Without return of the unit, it is not possible to determine if the balloon was eccentric, ruptured, or if there were other damage or defect on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Further evaluation regarding supplier related quality issues is under investigation.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 the pulmonary artery wedge pressure values of a swan ganz catheter were unstable and fluctuating widely on the first day of use.The issue was resolved by replacing the catheter.The customer suspected that the fluctuated pawp values were observed due to the potential eccentric balloon or balloon rupture.However, balloon rupture was not confirmed after the catheter removal.No abnormal waveform or error message was observed on the monitor.The patient was not treated based on the incorrect value.The incorrect value and the waveform matched.No data log was provided.There was no occlusion, leakage or kink noted in the catheter.The fluctuated values were not affected by the patient condition.Balloon integrity was checked before use and no balloon issue was detected.No information was available regarding indicated and expected values or if other troubleshooting was performed.A disposable pressure transducer was not replaced.Patient demographic information was requested but unavailable.The device was discarded at the hospital.There were no patient complications reported.

Manufacturer Narrative

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.

• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15161314
• MDR Text Key: 304834304
• Report Number: 2015691-2022-07155
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/15/2024
• Device Model Number: 131F7J
• Device Lot Number: 64264232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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