MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ VIP/OXIMETRY THERMOD; CATHETER

Model Number 782F75M

Device Problem Incorrect Measurement (1383)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

It was reported that, during use of this swan-ganz catheter model 782f765m, lot number unknown, the catheter was reading 1 degree celsius higher than the oral temperature.The monitor in use was a philips monitor.There was no patient injury.The device is available for return.

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.The device history record review could not be completed as the lot number is unknown.

Manufacturer Narrative

One 782f75m catheter, with a non-edwards contamination shield was returned for evaluation.The reported issue of inaccurate temperature was unable to be confirmed.The thermistor connector was able to be connected to the lab 70cc2 cable without difficulty.The catheter was submerged in a 36.9 degrees celsius water bath and read 37.0 degrees on the vigilance ii monitor.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.All through lumens were patent without any leakage or occlusion.A cut down was performed on the thermistor connector and there was no visible abnormality.An engineering evaluation was assigned to the manufacturing site for further 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 part of this monthly review.

• Brand Name: SWAN-GANZ VIP/OXIMETRY THERMOD
• Type of Device: CATHETER
• 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: 15459397
• MDR Text Key: 306250197
• Report Number: 2015691-2022-07976
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 782F75M
• Device Catalogue Number: 782F75M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• 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