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

Model Number 774F75

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

It was reported no cco measurements of a swan ganz were displayed when resuming a heart lung machine, even though the measurements were initially measured during procedure without issues.An error message of check thermal filament connection was displayed on the monitor.The cable was replaced, but the problem was not solved.The replacement of the catheter was not performed.There were no patient complications reported.Date of event is unknown.

Manufacturer Narrative

The reported event of cco measurement issue was confirmed.Catheter was connected to hemosphere monitor and error message of check thermistor connection and no blood temperature was shown.Continuity testing revealed that the thermistor circuit had a full open condition.Both thermistor leadwires were found broken at 19 cm proximal from catheter tip, the broken site was located under the thermal filament.It was confirmed that thermistor circuit was continuous from the broken site to thermistor bead and from the broken site to thermistor connector.As received, distal bonding site of thermal filament cover was torn.It was unable to determine if edges matched up.No other visible damage was observed on thermal filament cover.Thermal filament circuit was continuous, there was no open or intermittent conditions.A kink was observed on the catheter body at 5.7 cm proximal from catheter tip.2 indentations were observed on the catheter body at 8.8 cm and 11 cm proximal from catheter tip.The locations of the kink and indentations were aligned to the location of connection area between non ew introducer and contamination shield.No visible inconsistence was observed on eeprom data.Resistance value of thermal filament circuit was measured 39.41 ohms, which was in specification per drawing 597754 rev w.Specification is 37.26 plus minus 3.64 ohms.After thermal filament cover and thermal filament were peeled off, no visible damage was observed on the catheter body.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for 5min.Without leakage.No other visible damage was observed from catheter body, balloon, and returned syringe.Further evaluation regarding supplier related quality issues is under investigation.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 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: 14987904
• MDR Text Key: 302165315
• Report Number: 2015691-2022-06728
• 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: 07/12/2022

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 Expiration Date: 10/25/2023
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 64025028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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