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

Model Number SWAN GANZ UNKNOWN

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 are well described in the literature.An unstable hemodynamic value can be an indication to the user to begin the troubleshooting process.If the clinician believes the patient¿s clinical manifestations do not correlate to the displayed values, it is common clinical practice to the abort the attempt to obtain further hemodynamic measurements.The catheter can be exchanged if desired.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 sicu unit has experienced issues with "extremely low ci values" over the past 4-6 weeks despite ¿everything else reading normal.¿ it is unknown if the ci values were inaccurate.The model and lot numbers are unknown, as the patients come up from the or with the catheters already in place.Per follow-up with the customer, she stated that unfortunately she usually hears about problems with the pulmonary artery (pa) catheters after the fact (¿a day or two later¿), when the catheter has already been removed.Consequently, she personally has not had the opportunity to assess or trouble shoot the issues related to the allegations of low cardiac output (co) values and is unable to provide any other concrete details.There is no product for return.It was noted by the customer that as a proactive measure moving forward, she recently sent out an email to staff asking them to save any problematic pa catheters and to include the patient demographics and a detailed description of said issue.Additionally, she also sent out an email to the mccu, cath lab, and anesthesia departments to contact her with any concerns/ issues.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8693812
• MDR Text Key: 148305483
• Report Number: 2015691-2019-02125
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1