MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 131F7J

Device Problem Deflation Problem (1149)

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

Event Date 07/15/2020

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 it was unable to deflate the balloon before use.It is unknown if the inflation syringe was removed from the gate valve or not.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The unknown yellowish material was sent to chemistry for ir spectrum and energy dispersive spectroscopy (eds) tests.The ir spectrum did not show distinct (peak) spectrum signature, therefore it was unable to match to a suitable material.Results from eds indicated the presence of the following elements: carbon, oxygen, sodium and chlorine.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Manufacturer Narrative

One swan ganz catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.Customer report of balloon deflation issue could not be confirmed during the analysis, however, contamination was found inside the gate valve.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.The specification for balloon deflation without a syringe attached is 4 seconds.An unknown yellowish material, approximately 1 mm x 1 mm in size, was observed inside the gate valve.The material was not detached during evaluation.The unknown material was removed and sent to chemistry for analysis.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned syringe.Balloon inflation testing was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.The lot number was obtained from the label of the returned device.A device history record review was completed and documented that device met all specifications upon distribution.A supplemental report will be sent with the chemistry investigation results.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.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have 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

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

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• 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: 10347801
• MDR Text Key: 202395156
• Report Number: 2015691-2020-12856
• 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,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: 131F7J
• Device Lot Number: 62780316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1