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

Model Number 746F8

Device Problem Material Rupture (1546)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.Customer report of balloon issue was confirmed; however, the balloon was not found to be ruptured.Balloon did not inflate due to leakage from 2 tears, approximately 0.5 mm and 0.5 mm x 1.0 mm, along the distal balloon bonding site.The edges of torn latex appeared to be different shapes and were not able to match up.It was able to insert the catheter into a lab 9 fr introflex introducer with contamination shield, which is the recommended size introducer per (b)(6) ifu.All through lumens were patent without any leakage or occlusion.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon issue was confirmed during the analysis.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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 common clinical 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.It is unknown if user factors may have contributed to the event.This incident occurred before use so there was no patient compromise noted.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.Reference mdr report number 2015691-2019-03880 for first catheter.

Event Description

It was reported that the balloon of the swan ganz catheter did not inflate after insertion, during use, although there was no problem at pretest prior to use.The balloon was found to be ruptured after removal of the catheter.The same problem occurred twice in a row.After the second failure of balloon inflation, the introducer was also exchanged.The third catheter was inserted via the second introducer using the same access site, and the problem was solved.The introducer used in this case was a teleflex arrow sheath introducer and it was sent to the manufacturer for evaluation.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP 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: 9215876
• MDR Text Key: 188735658
• Report Number: 2015691-2019-03881
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 62294341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1