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

Model Number 777F8

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

One 777f8 catheter with a monoject limited volume syringe were returned for examination.The reported event of "chek thermal filament connection" error was confirmed.The error message "check thermal filament connection" appeared when the catheter was connected to laboratory hemosphere monitor.The thermal filament cover was torn at approximately 22cm proximal from the distal tip and the thermal filament trace was damaged.The thermal filament trace edges at the break location appeared to match.However, the thermal filament cover edges at the torn location did not appear to match.Continuity test found that the thermal filament circuit had an open condition on the thermal filament.There was no open or intermittent condition in the thermistor circuit.The eeprom data was found to be normal, both the stored data and the computed data matched.The catheter passed in-vitro calibration with lab cal-cup.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were found to be patent without any leakage.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.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.In this event, a section of the thermal filament trace edges was torn, and the edges did not match up.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.It is common clinical practice to check device integrity by flushing it in order to detect any leakage condition before use of the catheter.When there are missing parts from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.No patient complications were reported due 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.

Event Description

It was reported that when the clinician hit the start button on the hemosphere monitor, nothing would happen when the start button was touched.The svo2 was populating, but there was no cardiac output (co) or systemic vascular resistance (svr) even after trying multiple 70cc2 cables.The connectivity was checked, and the central venous pressure (cvp) was populating on the hemosphere monitor.The error message observed was fault: chek thermal filament connection.The swan was not replaced.No patient complications were reported.

Manufacturer Narrative

Udi number (b)(4) was inadvertently left off of the initial submission.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11935476
• MDR Text Key: 254916208
• Report Number: 2015691-2021-03289
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 08/19/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63340166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 53