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

Model Number 746F8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

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

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.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 pulmonary artery pressure (pap) was rapidly increased by approximately 150 mmhg after about an hour and a half of the start of the cardiac surgery and it became unable to measure pap during use.The catheter was placed without issue and measurements of cco, svo2 and pap were obtained from the beginning of surgery.About an hour and a half later, almost at the same time of cardiopulmonary bypass (cpb) initiation, acute elevation of pap by approximately 150 mmhg was observed and it became unable to measure pap.The customer suspected the catheter was accidentally sewn or that some other incident had occurred.The catheter was removed.The removed catheter was primed from the pa distal lumen hub with saline solution and substantial resistance was felt although saline solution came out from the distal port.By visual inspection, part of the thermal filament seemed to be narrowed.No problem was confirmed at priming prior to insertion.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 20.5 and 84.5 cm proximal from the catheter tip.Customer report of pressure measurement issue was not able to be confirmed during the evaluation; however, the catheter was found to be kinked at approximately 22 cm proximal from the catheter tip.A lab 0.021" angle tip guidewire (recommended size per japan ifu) was inserted from the distal lumen hub and from the catheter tip of returned catheter and became stuck at the kinked area.It was able to inject air or water into the distal lumen without issue.No other visible damage or inconsistency to the catheter body, balloon or returned syringe was observed.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 fault messages appeared on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 minutes without error.The thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistency was observed on eeprom data.Resistance value of the thermal filament circuit was within specification, measuring 38.40 ohms.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 eyes.The lot number was obtained and a device history record review was completed and documented that device met all specifications upon distribution.Customer report of pressure measurement issue could not be confirmed during the analysis, as the device responded appropriately during functional testing; however, the catheter was found to be kinked.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.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP 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: 8538010
• MDR Text Key: 143239453
• Report Number: 2015691-2019-01410
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 61693442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1