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 Increase in Pressure (1491); Insufficient Flow or Under Infusion (2182)

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

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that during use of a swan ganz catheter used in cardiothoracic ot, fluid was observed running up the line and there was a high-pressure alarm on the iv pumps.The catheter ¿appeared to be delivering highly inconsistent amounts of medication.¿ propofol was being delivered via the ¿blue lumen¿ and was observed to be coming backwards up the ¿yellow lumen.¿ noradrenaline and milrinone were also infusing and the iv pumps periodically alarmed with high pressure.The iv pumps were noted to be fresenius kabi volumetric pumps and alaris syringe driver pumps.No error messages were observed on the monitor.No inaccurate values were reported.There was no patient injury.The model and lot number of the suspect device are unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 831f75 swan-ganz catheter with a detached non-edwards introducer and a non-edwards contamination shield.As received, all through lumens were patent without any leakage or occlusion.Also, no fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor read 37.0°c when submerged into a 37.0°c water bath.The thermistor temperature reading was within specified accuracy, per the vigilance manual.The balloon inflated clear and concentric, and remained inflated for more than 5 timed minutes without leakage.No visible damage was observed from the catheter body.The customer report of fluid "down the blue lumen was coming backwards up the yellow lumen" was not confirmed on evaluation, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.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 is well described in the literature.High pressure alarms on the iv pump can be indicative of an occlusion in the line.In this case, the fluid was backing up into different lumens in the catheter with high pressure alarms and the user stated that medication was not being delivered consistently.High pressure alarms should alert the user to an issue with the system and troubleshooting should be started.Medication not being delivered consistently could cause a deterioration in the patient¿s condition and may necessitate additional interventions.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.

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: 8713222
• MDR Text Key: 148972216
• Report Number: 2015691-2019-02231
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR