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

Model Number 774F75

Device Problems Deflation Problem (1149); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body between 53.8 cm and 108 cm proximal from the catheter tip.As received, blood was observed inside the balloon and it was not able to inflate or deflate the balloon due to occlusion with clotted blood.It was not able to perform in-vitro calibration because the catheter tip could not be inserted into cal-cap.Blood was observed inside optical module connector.As received, the thermal filament and the cover were damaged at approximately 24 cm proximal from the catheter tip.The edges of the thermal filament and the cover were uneven and folded, thus it was not able to check if the edges matched up.After removing the thermal filament and the cover, two punctures, 2.5 mm and 1 mm, on the opposite side of each other, were found on the catheter body at approximately 24 cm which was the same position with the thermal filament and cover damaged area.The optical module, thermistor and thermal filament extension tubes were cut in half just distal of the connectors for leak testing.Leakage was found from the puncture when air was injected into balloon inflation lumen and optical module lumen.Leakage was found from the other puncture when air was injected into the distal lumen.The proximal injectate lumen was patent without any leakage or occlusion.Upon removing the optical fiber, a kink was observed at approximately 24 cm which was the punctured area, but no light leakage was found from the fiber.No visible damage to the balloon, balloon bonding sites or returned syringe was found.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.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of svo2 measurement issue could not be confirmed during evaluation; however, catheter damage and balloon deflation 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

It was reported that the svo2 value was observed to be inaccurate during aortic arch replacement surgery on the first day of use with a swan ganz catheter.The customer checked the catheter and noticed that blood had leaked from the connection site between the catheter and the om-2 module.Some resistance was felt when the anesthesiologist attempted to remove the catheter on the following day.The cardiologist managed to remove the catheter safely under radiography with some resistance.After removal, a kink was found at the end of the thermal filament.In addition, the balloon remained inflated and a clot was observed inside the balloon.The customer commented that resistance issue may have occurred because the inflated balloon got stuck.It was unable to obtain the indicated svo2 value, the expected value, if an error message was displayed on the monitor, or if any trouble shooting was performed.It is unknown if the patient was treated based on the incorrect value or if the value was affected by the patient condition.It is unknown if the inflation syringe was removed from the gate valve at the removal of the catheter.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: 10081045
• MDR Text Key: 192448225
• Report Number: 2015691-2020-11929
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 05/12/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1