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

Model Number 831F75P

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that during use in an elective cardiac surgery patient (avr and cabgs) with an uncomplicated early post-operative icu course there was normal appearance of pulmonary artery catheter (pac) on chest xray (cxr) and normal waveform and pac derived measurements.There was resistance with removal of the swan ganz catheter while trying to withdraw it through the sheath.Therefore, they immediately ceased the attempted removal.The cxr were reviewed and no kinks or knots were noticed, so an attempt was made to remove the catheter and sheath together.Initially some mild resistance was felt, and they were able to pull out the sheath and catheter together to about 10-12cm when resistance was felt so the withdrawal was ceased.The catheter was now at about 30cm at the skin and in the right ventricle based on the waveform and cxr.The surgeon then agreed to remove the pac in the operating theatre, which was then undertaken a couple of hours after.Removal required the patient to undergo a general anesthetic with reintubation and surgery with resternotomy to remove the pac.At reoperation it was found that the catheter had an extensive split along a mid-portion, which resulted in it bunching up.There was no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

One 831f75 with a monoject limited volume syringe, non-edwards contamination shield and a non-edwards introducer were returned for examination.The reported event "catheter damaged" was confirmed.The catheter tip was broken at approximately 13 cm of the catheter body and catheter tip including balloon was not returned.The cross surface of the broken tube appeared uneven and rough.The catheter body appeared to be cut horizontally from 13 cm to 24 cm of the catheter.Both the thermistor lumen and the proximal injectate lumen were exposed.Some parts (from approximately 13cm to 18.5cm, 19cm to 20.5cm and 21.5cm to 22cm of the catheter body) of the damaged catheter appeared to have two smaller lumens where the proximal injectate lumen is located.The thermistor leadwires in the catheter body, from 60 to 70 cm proximal from the catheter tip, were bunched up.The catheter body had indentations at 69cm and 72cm of the catheter.The locations of indentations were aligned to the location of housing and the flexible sheath body of the returned introducer.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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 is well described in the literature.In this case, the surgeon experienced catheter withdrawal difficulty and the patient ultimately required additional intervention (resternotomy) to retrieve the catheter.It is unknown whether user or procedural factors played a role in this 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.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) 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: 11346686
• MDR Text Key: 232587305
• Report Number: 2015691-2021-01298
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention