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

Model Number 774F75

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that during use in a patient with this swan ganz catheter, the central venous oxygen saturation (scvo2) would not display.A new catheter was used to continue.The new catheter was inserted using a new guidewire and introducer through a new insertion site.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are unable to be obtained.

Manufacturer Narrative

One swan-ganz catheter with a 1.5cc syringe were returned for examination.The reported event of svo2 values issue was not confirmed.The catheter passed in-vitro calibration with lab cal-cup.The catheter was submerged in a 37.0 °c water bath and read 37.0 °c on a vigilance ii monitor.Thermistor temperature reading accuracy is +/- 0.3 °c per vigilance ii manual.The thermistor and thermal filament circuit were continuous.There were no open or intermittent conditions.The eeprom data was found to be normal, both the stored data and the computed data matched.The resistance value of the thermal filament circuit was measured and found to be within specification.However, the balloon inflated clear but eccentric and remained inflated for 5 minutes without leakage.The balloon was found to have an eccentricity that was out of specification.The balloon shows no sign of deterioration.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from the catheter body and returned syringe.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the introducer, to consider the potential benefits in relation to the possible complications.The techniques for insertion and the occurrence of complications is well described in the literature.In this case, the patient required a new stick to insert a new catheter and guidewire.It is unknown if user or procedural factors may have contributed to this 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.Udi # (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10113015
• MDR Text Key: 194629030
• Report Number: 2015691-2020-12041
• 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
• Report Date: 04/17/2020

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: 08/27/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61500030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: 05/16/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 07/23/2020
• Supplement Dates FDA Received: 06/18/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1