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 Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that the proximal injection lumen hub of the swan ganz pacing catheter detached during use and blood leakage occurred.No additional treatment was required.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Additional information was obtained that the issue was identified during cagb bypass procedure.Use of the catheter was discontinued due to the blood leakage.One catheter with attached monoject 1.5 cc limited volume syringe at gate valve and two non-edwards three-way stopcocks at pa distal hub and proximal injectate hub were returned for evaluation.A non-edwards contamination shield was located on the catheter body between approximately 30 cm and 106.7 cm proximal from the catheter tip.As received, extension tube of proximal injectate was completely detached from the backform.The 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.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.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.In the event that a lumen detaches from the hub, there is potential for an air embolism or blood loss, which could cause injury to the patient.The catheter should be clamped and exchanged if this issue occurs.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.

• 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
• MDR Report Key: 11770808
• MDR Text Key: 252339145
• Report Number: 2015691-2021-02784
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: TOE135F75
• Device Lot Number: 63366249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Patient Sequence Number: 1