MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 777F8

Device Problems Backflow (1064); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 777f8 catheter with a monoject limited volume syringe and a non-edwards contamination shield.The catheter body had 3 cuts measuring 0.1 inches, 0.02 inches, and 0.04 inches long at approximately 87cm proximal from the distal tip.The proximal injectate lumen had leakage through the two larger cuts, which only entered the proximal injectate lumen.The smallest cut was surface damage.A section measuring approximately 0.1 inches x 0.04 inches was cut off of the catheter body and was not returned.All other through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric, and remained inflated for 5 timed minutes without leakage.The customer report of a leakage issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 are well described in the literature.In this event, a section of the catheter body was cut off and was not returned.It is standard clinical practice to check device integrity by flushing it in order to detect any leakage condition before use of the catheter.When there are missing parts 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.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 by the nurse that while caring for a (b)(6) year-old male patient who was up in a chair s/p cabg, blood started to flow back through a small hole in the swan-ganz catheter.It was noted that the swan had a protective cover over it.The patient was returned to the bed and the swan was pulled and replaced with a new one.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7939099
• MDR Text Key: 123955084
• Report Number: 2015691-2018-04076
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 102