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

Model Number SWAN GANZ UNKNOWN

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product(s), it is not possible to determine if damages or defects exist on the product(s), nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number(s) were 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.With any hemodynamic monitoring, hemodynamic values can change quickly and dramatically.The displayed value should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort the attempt to obtain measurements and the catheter can be exchanged if desired.It is unknown whether user or procedural factors 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 to the edwards representative, per the icu manager, that it was brought to her attention that multiple nurses had recently been noticing issues with the swan-ganz catheters not reading correctly at times.For example, the cardiac index (ci) value would read as 3 and then suddenly read as 0.9.Additionally, the catheters would sometimes ¿read oddly¿.The customer reported the issue due to concern there had been a change with the vendor or type of catheter that they are using.There was no allegation of any patient injury.No additional details were provided pending ongoing follow-up, including specific dates of occurrence, model and lot number(s) of the suspect catheters, patient demographics, and availability of any suspect devices for return.

• 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 CA 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn thomas ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 9655754
• MDR Text Key: 195068738
• Report Number: 2015691-2020-10340
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1