MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH; SWAN-GANZ PACING CATHETER

Model Number TOE135F75

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe, three non-edwards three-way stopcocks with a tube at the pa distal hub and proximal injectate hub was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 17.5 cm and 66 cm proximal from the catheter tip.As received, the extension tube of the proximal injectate was completely detached from the backform.Unknown white material was observed on the extension tube between 2.5 mm and 8.0 mm from the end of the distal side.The material was not detached from the extension tube during evaluation.The unknown material was removed and sent for chemistry analysis.Pa distal lumen was patent without any leakage, or occlusion.No other visible damage to the catheter body, balloon, or returned syringe was found.The balloon inflated clear, concentric, and remained inflated for 5 minutes without leakage.Visual examinations were performed under microscope at 10x magnification and with the unaided eye.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of, "the proximal injectate lumen was completely detached from the backform," was confirmed.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.

Event Description

It was reported that the proximal injectate lumen of the swan ganz catheter was completely detached from the backform during use.The catheter was inserted to the patient for use in minimally invasive cardiac surgery, aortic valve replacement (mics+avr), procedure.The patient was transferred to icu post procedure with the catheter remaining in situ for cvp measurement.At 3am the next day, it was noticed that the patient's bed was wet.The catheter was checked and it was identified that heparinized saline solution had leaked.The icu physician immediately removed the catheter.The patient was a (b)(6)-year old female.There were no patient complications reported.

Manufacturer Narrative

The unknown white material was sent to chemistry for ir spectrum testing.The sample spectrum showed similar absorption characteristic when comparing to poly (2-ethylhexyl acrylate).An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• Brand Name: SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH
• Type of Device: SWAN-GANZ PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10906322
• MDR Text Key: 219192916
• Report Number: 2015691-2020-14715
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOE135F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR