MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION PACEPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 931F75

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

One 931f75 catheter and a monoject limited volume syringe were returned for examination.The reported event of "disconnected" was confirmed.The rv pacing/infusion extension tube was broken off at the hub.No other visible damage was observed on the catheter body.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures inherently involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is standard clinical practice to inspect these devices prior to use on a patient during set-up and flushing.If a lumen disconnects from the hub during use, there would be risk of blood loss.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 ¿the nurse was trying to disconnect the rv port infusion and the orange part came disconnected from the actual tubing on the pa catheter¿.No patient complications were reported.Patient demographics were unable to be obtained.

Manufacturer Narrative

The ifu does not contain specific instructions regarding how to disconnect the rv pacing/infusion hub but contains the following instructions to ensure patency and to remove air from the catheter: "catheter preparation" section 1.Flush catheter lumens with a sterile solution to ensure patency and to remove air.3.Connect the catheter¿s injectate and pressure monitoring lumens to the flush system and pressure transducers.Ensure that the lines and transducers are free of air.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

• Brand Name: SWAN-GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 11050259
• MDR Text Key: 232589118
• Report Number: 2015691-2020-15161
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 931F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1