MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 774F75

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer with contamination shield was located on the catheter body from tip to 87.5 cm proximal from tip.Blood was visible on catheter body.As received, the thermal filament and the cover was damaged at approximately 21.9 cm from the catheter tip.The size of the damaged area was 1.5 mm x 2.0 mm.The edges of the thermal filament appeared to match up, however, the edges of thermal filament cover were uneven and folded, thus it was not able to check if the edges matched up.The catheter was connected to vigilance ii monitor and "check thermal filament connection" error message was shown.An intermittent condition was confirmed on the thermal filament.After removing the thermal filament and the cover, the catheter body was also found to be damaged.The damage on the catheter body did not enter any lumens.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.The thermistor circuit was continuous and there were no open or intermittent conditions observed.No visible inconsistency was observed on eeprom data.Thermal filament connector was opened with no visible abnormalities.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage to the balloon, returned syringe or connectors was found.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of cco measurement issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have contributed to the stated event.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.

Event Description

It was reported that the error message ¿check thermistor connection¿ was displayed on the vigilance 2 monitor and it became unable to measure cco after the patient was moved to icu on the first day of use.The measurement was running properly in the operation room.The catheter and 70cc2 cable were reconnected but the problem was not solved.The 70cc2 cable passed the test.Patient demographic information requested but unavailable.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ 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 ; 9492500249
• MDR Report Key: 11069865
• MDR Text Key: 228172991
• Report Number: 2015691-2020-15239
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

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 Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63120686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2020
• 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