MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75

Device Problems Incorrect Measurement (1383); High Readings (2459)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.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.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, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings 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.(b)(4).

Event Description

It was reported that during use, a swan-ganz catheter kept reading high pulmonary artery pressure (pap), despite replacing the cable and constantly zeroing.The displayed values were not provided.There was no patient injury.The catheter will not be returned due to contamination.Patient demographics were requested and not provided.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) 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: 7862560
• MDR Text Key: 120109282
• Report Number: 2015691-2018-03740
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Device Lot Number: 61388537
• 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