MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/18/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of leakage issue was not confirmed.Distal side and proximal side of thermal filament cover bonding site was torn and blood was entered inside of cover.The edges of torn sections appeared to match up.No other visible damage or abnormality was observed from catheter body, balloon, hubs and returned syringe.All through lumens were patent without any leakage or occlusion.Balloon inflated clear, concentric and remained inflation for more than 5 mins without leakage.Catheter passed the pressure test with lab dpt.Per the ifu, the incidence of complications increases significantly with indwelling periods longer than 72 hours.Further evaluation regarding supplier related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Event Description

It was reported air was observed in the ecmo circuit.Hospital staff suspect that the cco catheter was the path of air bubbles.The catheter was used on the patient for more than 2 weeks without any issues.Per the sales rep., the hospital staff commented that the air might have accidentally entered due to an error in operating a three-way stopcock.The cco catheter was removed from patient and not replaced with a new catheter.There were no patient complications reported.

Manufacturer Narrative

The reported event could not be confirmed through the product evaluation as the device responded appropriately during testing.There was no fault found with the catheter that would cause the air to enter the ecmo system through the catheter.Per the sales representative, the hospital staff commented that the air might have accidentally entered due to an error in operating a three way stopcock.The stopcock was on the side port of a teleflex sheath introducer.According to representative, the medical examiner commented that there was a possibility of the air entering the system through the sheath introducer.No evaluation was completed to the introducer as it is a non edwards device.Per evaluation findings and comments by medical examiner, this is no longer a reportable 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 a part of the monthly review.

• Brand Name: SWAN GANZ CCOMBO
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14982787
• MDR Text Key: 304548422
• Report Number: 2015691-2022-06717
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1