MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of cco measurement issue was not able to be confirmed during evaluation.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is plus negative 0.3 c per hemosphere manual.The catheter ran cco in 37.0 c water bath on hemosphere monitor for 5 mins.Without error.Thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistence was observed on eeprom data.Resistance value of thermal filament circuit was measured 40.11 ohms, which was in specification per drawing (b)(4) rev y.Specification is 37.26 plus minus 3.64 ohms.Both thermistor and thermal filament connectors were opened and found no visible inconsistencies.As received, distal heater bonding was torn, and blood was observed in heater shrink wrapping.Torn edges were not able to match up.2 indentations were observed on catheter body at 41.8 cm and 42.5 proximal from catheter tip, where the connection area of non ew introducer and contamination shield adapters located.No other visible damage or inconsistency was observed from catheter body, balloon or returned syringe.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.Further evaluation regarding supplier related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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 a swan-ganz cco catheter was connected to a hemosphere monitor and continuous cardiac output measurement could not be started.An error message of check thermistor connection appeared on the monitor.The catheter was used without replacement.The customer suspected it was a malfunction of the catheter since a cable testing revealed that the cable was normal.No injury or complication occurred.

• Brand Name: SWAN-GANZ CCOMBO
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14575120
• MDR Text Key: 300918519
• Report Number: 2015691-2022-05992
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• 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
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/02/2022
• 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