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

Model Number 777F8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683); High Test Results (2457)

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

Event Date 11/26/2018

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.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that an inaccurate pulmonary artery pressure (pap) value was indicated during use.Indicated pap reading was 30 mmhg although the expected value was 10 mmhg.The waveform was able to be confirmed.The customer was able to zero before the initial use but was unable to zero during use.The swan ganz catheter was exchanged and the problem was solved.The value after exchange of the catheter was ~ 15 mmhg.The edwards lifesciences disposable pressure transducer (dpt), from an unknown model number, was not considered suspect as the issue was solved when the catheter was exchanged using the same dpt.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter, model 777f8, with attached monoject 1.5 cc limited volume syringe was returned for evaluation.Without the return of the pressure monitoring unit, customer report of pressure measurement issue could not be confirmed.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency to the catheter body, connectors, balloon or returned syringe was observed.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 38.43 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 eye.Customer report of pressure measurement issue could not be 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.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.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/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: 8171513
• MDR Text Key: 131333020
• Report Number: 2015691-2018-05336
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

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: 07/10/2020
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61444619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/20/2018; 07/23/2020
• Supplement Dates FDA Received: 01/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1