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

Model Number 774F75

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the swan ganz catheter became unable to measure cco during use after surgery.Reportedly, the cco measurement was unstable during surgery, although it is unknown if ¿unstable¿ meant the indicated value was not stable or the measurement was intermittent.The error message ¿check thermistor connection¿ was displayed on the monitor.The cable and the monitor were replaced but the problem was not solved.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The lot number of the catheter was obtained from eeprom data.Therefore, a device history record review was completed and documented that device met all specifications upon distribution.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe, one three-way stopcock, and one pressure tubing set was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body from 16 cm and 89 cm proximal from tip.Clotted blood was observed from the catheter.The catheter was connected to vigilance ii monitor and "check thermal filament connection" error message was shown.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.The thermistor circuit was continuous and there was no open or intermittent condition observed.No visible inconsistency was observed on eeprom data.Resistance value of the thermal filament circuit was within specification, measuring 37.02 ohms.The thermal filament connector was opened, and corrosion was observed from the circuit board.No visible damage was observed from the thermal filament connector pins and the bonding site between the leadwires and housing in the thermal filament connector.Continuity testing confirmed a short condition between the leadwires in the circuit board.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No visible damage or inconsistency to the catheter body, balloon or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eye.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

Additional information was received that the initial complaint description was incorrect.It was confirmed that cco measurement became intermittent after the surgery not during the surgery.On the following day the swan ganz catheter became unable to measure cco.Also, it is unknown when the error message was displayed on the monitor.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 9553528
• MDR Text Key: 193618294
• Report Number: 2015691-2020-10033
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2019

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: 09/19/2021
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62581978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/17/2020; 02/05/2020; 07/23/2020
• Supplement Dates FDA Received: 01/30/2020; 02/19/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1