MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ OXIMETRY TD CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number SWAN GANZ UNKNOWN

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any 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.With any hemodynamic monitoring, values can change quickly and dramatically, and should correlate with the patient¿s clinical manifestations.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 that during use of the swan-ganz catheters, the customer felt they¿ve been receiving ¿inconsistent ci and svo2 values.¿ per hospital protocol, they run a mixed venous oxygen saturation (svo2) on patients with a cardiac index (ci) less than 2.0, and from that svo2 value, they were making assumptions for what the ci ¿should be." the customer uses philips (non-edwards brand) bedside monitors for the calculation of ci not edwards.No error messages are believed to have been noted.The customer reported this to have occurred in 10 instances; however, have not provided a response to follow-up attempts for the affected model and lot number(s), specific dates of occurrence, displayed values vs.Expected values, any observed error messages and troubleshooting methods, and patient demographics for each of the reported 10 catheters.Additionally, the customer has not provided a response to follow-up attempts at determining the availability of any/all of the 10 suspect devices for return.There was no allegation of any patient injury or inappropriate treatment resulting from the ci values.Of note, the edwards reps performed a follow-up walk through with the customer in each of the cardiac units to answer questions or concerns from staff, for which they didn¿t encounter any.The representatives for philips brand products had also been on site prior to the edwards representatives visit, and were reported to have confirmed there were no issues on their end.

Manufacturer Narrative

Corresponding mdr numbers: 2015691-2018-04437, 2015691-2018-04438, 2015691-2018-04439, 2015691-2018-04440, 2015691-2018-04441, 2015691-2018-04442, 2015691-2018-04444, 2015691-2018-04445, 2015691-2018-04446.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ OXIMETRY TD CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8017757
• MDR Text Key: 126969832
• Report Number: 2015691-2018-04443
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K905458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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