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

Model Number 777F8

Device Problem Incorrect Measurement (1383)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been returned but the product evaluation has not been completed yet.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.

Event Description

It was reported that during use of this swan-ganz catheter, the svo2 value was suspected to be inaccurate.The svo2 value shown on the monitor was 15 percent although the expected value was 60 percent.There was no error message displayed.There was no information available regarding if any treatment was given to the patient based on the inaccurate value or if the value was affected by the patient condition.Relevant data was not provided.Per troubleshooting, the svo2 values of other sites (right atrial pressure and right ventricular pressure) were measured, and they both showed around 60 percent.There was no occlusion, leakage or kink confirmed in the catheter, and no replacement was performed.Patient demographics were requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product lab received one model 777f8 catheter with attached monoject 1.5 cc limited volume syringe, 3 three-way stopcocks and a non-ew introducer set with non-ew contamination shield which located 37cm to 72.5cm proximal from the tip.The reported issue of inaccurate svo2 values was unable to be confirmed.The catheter passed in-vitro calibration on a hemosphere monitor.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.The distal thermal filament cover bonding site was found to be torn.The torn edges appeared to match up.Two indentations were observed at 50.5 cm and 51.5 cm proximal from the tip.The location of the indentations aligned to non-ew contamination shield adapter.No other visible damage was observed from catheter body.The catheter passed the attenuation test.The lot number was received.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was completed to assess for any manufacturing-related processes which could be correlated to the complaint.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing non-conformance.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 CCOMBO V CCO
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18685064
• MDR Text Key: 335122682
• Report Number: 2015691-2024-00938
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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