MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, CONTINUOUS FLUSH

Model Number 139HF75P

Device Problems Material Rupture (1546); Material Separation (1562); Component Missing (2306); Failure to Advance (2524); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the 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.It is standard practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.It is unknown whether user or procedural factors 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 during an elective avr/mvr (aortic and mitral valve replacement) and tricuspid annuloplasty in a (b)(6) year-old female, the balloon of this swan-ganz catheter detached from the catheter body.The insertion of the catheter was noted to have been ¿easy and uncomplicated.¿ per routine, the swan was then withdrawn to the sheath to allow for placement of bicaval venous cannulae, which would provide intraoperative perfusion during the bypass.The swan was withdrawn to the sheath for a total of three hours during the bypass.Post-bypass, the clinician attempted to refloat the swan but was unable to advance it due to resistance.The catheter was withdrawn back up to the sheath, with the clinician noting that no resistance was encountered at any stage during balloon inflation.Since the clinician suspected the balloon had ruptured, further attempts to advance the catheter were then abandoned and the patient was transferred to the intensive care unit post-operatively.Unfortunately, when the swan and the introducer were removed, the balloon was missing.The sheath was flushed and examined, and the balloon remnant was found within the sheath.There was no patient injury.The device was discarded by the customer.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7737244
• MDR Text Key: 115768582
• Report Number: 2015691-2018-03084
• Device Sequence Number: 0
• Product Code: KRA
• PMA/PMN Number: K924661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/12/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 139HF75P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR