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

Model Number 774F75

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe.As received, a puncture, approximately 1.5 mm x 1.0 mm, was observed from the catheter body at 27 cm proximal from the catheter tip.Clotted blood was observed outside and inside of the thermistor connector.The thermistor was submerged in a 37.0 c water bath and read 35.9 c on the vigilance ii monitor.Clotted blood created short conditions.No visible inconsistency was observed on eeprom data.Resistance value of the thermal filament circuit was within specification, measuring 38.87 ohms.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.The thermal filament and optical module connectors were opened and no visible abnormality was observed.No other visible damage or inconsistency to the catheter body, balloon, or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.3 cc air.Visual examination was performed under microscope at 20x 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 ¿inaccurate blood temperature¿ issue and ¿blood leakage from the thermistor¿ were confirmed during evaluation.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.Blood temperature can be verified by various methods.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 inaccurate blood temperature readings were observed during use.Blood leakage was observed from the thermistor line of the swan ganz catheter.The patient was not treated based on the incorrect value.It is unknown if an error message was displayed.It is unknown if an occlusion, other leakage or kink was noted in the catheter.The value was not affected by the patient condition.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

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: 8286929
• MDR Text Key: 134605764
• Report Number: 2015691-2019-00298
• 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
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61427674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1