MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT; SWAN-GANZ CATHETER

Model Number TS105F5

Device Problem Deflation Problem (1149)

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

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that the clinician was unable to deflate the balloon of the swan ganz catheter during use.It is unknown if the inflation syringe was removed from the gate valve.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached bd 1.0 ml syringe was returned for evaluation.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.The balloon deflated within 1 second without a syringe attached.The specification for balloon deflation without a syringe attached is 4 seconds.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned syringe.Balloon inflation test was performed using returned syringe with 0.8 cc air by holding the balloon under water for 5 minutes.Visual examination was performed under microscope at 10x magnification and with the unaided eye.Customer report of balloon deflation issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry, leakage condition or deflation issue before use of the catheter.In this event, there were no patient complications noted.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 TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9727925
• MDR Text Key: 192254624
• Report Number: 2015691-2020-10589
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2021
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 62644212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1