MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME MONITOR; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 774F75

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 774f75 swan-ganz catheter.The customer report of leakage was confirmed.A cut of approximately 2 mm in length was found on the catheter body at 11.5 cm from the backform.The cut affected proximal injectate lumen.Edges of the cut did not appear to match up.No leakage was observed from all other through lumens.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage was found from balloon and returned syringe.A supplemental report will be forthcoming when the investigation is completed.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 that blood leakage was observed at approximately 1 cm outside the body from insertion site of the neck during use of this swan-ganz cco catheter.The event occurred in an adult patient.It is unknown what surgery the catheter was used for.The amount of leakage is just enough to seep when covered with gauze, but not a large amount.No additional treatments such as blood transfusion nor extension of hospitalization was required.The cause of the leakage was not identified and a ct scan was performed.There were no patient complications reported.

Manufacturer Narrative

An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.As part of this investigation a process evaluation was performed in the manufacturing line in order to verify if the reported issue could be caused during the manufacturing process.The process engineer subject matter expert (sme) was consulted and it was confirmed that as part of the manufacturing process in the step of cut to length a sharp object is used to cut the catheter to usable length.However, this operation is performed where the thermistor is placed in the catheter.As per product evaluation results, the cut of approximately 2 mm in length was found on the catheter body at 11.5 cm from the backform; which was far enough into the manufacturing process where a sharp object is used in the catheter.Based on this, there is not clear evidence that could conclude that the defect reported was caused of the manufacturing.However, a personnel awareness was performed to the manufacturing operators during this process evaluation.Based on this results, no root cause for the reported issue could be identified as part of this investigation; edwards will monitor all similar incidences and actions will be taken as applicable.As part of the manufacturing process 100 % visual inspection is conducted as well as 100 % leak test is performed.Quality assurance inspection is also performed to ensure that all samples are manufactured as per the requirements established.A device history record review was completed and documented that device met all specifications upon distribution.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: CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME MONITOR
• 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: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18754612
• MDR Text Key: 335966855
• Report Number: 2015691-2024-01205
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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 Model Number: 774F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/26/2024
• 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