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

Model Number 777F8

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.Balloon was found to be ruptured at the central area of the balloon and the ruptured edges of balloon latex were not able to match up.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency to the catheter body or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and unaided eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon inflation issue was confirmed during the evaluation.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 or procedural factors may have contributed to the 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 balloon of the swan ganz catheter did not inflate during balloon test before use.The catheter was not removed from the tray when balloon inflation test was performed.Patient demographic information requested but unavailable.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV 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
• Manufacturer (Section G): EDWARDSLIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 11476705
• MDR Text Key: 243755285
• Report Number: 2015691-2021-01846
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2021

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 Expiration Date: 07/20/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63281667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1