MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH; PACING CATHETER

Model Number TOE135F75

Device Problem Material Separation (1562)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe at gate valve was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 12.5 cm and 81.7 cm proximal from the tip.Extension tube of the proximal injectate was detached from the backform.Clotted blood was observed on the catheter body.As received, extension tube of the proximal injectate was completely detached from the backform.Pa distal lumen was patent without any leakage or occlusion.No other visible damage to the catheter body, balloon, or returned syringe was found.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.Visual examinations were performed under microscope at 10x magnification and with the unaided eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of detached component issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Event Description

It was reported that the injectate lumen of the swan ganz pacing catheter detached from the backform during use.The issue was resolved by exchanging the catheter.No pressure parameter issues were observed during use of the catheter.No leakage of blood or saline solution was reported.Patient demographic information requested but unavailable.No additional treatment or patient complications were reported.

• Brand Name: SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, 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: 12080449
• MDR Text Key: 259250625
• Report Number: 2015691-2021-03801
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822723
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: TOE135F75
• Device Lot Number: 63507832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1