MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 774F75

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

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 has been initiated and a supplemental report will be sent with the investigation results.

Event Description

It was reported that during use of a swan-ganz catheter, the central venous pressure (cvp) and the pulmonary artery pressure (pap) values were double.As per follow-up with the customer, it was clarified that the values were higher than the normal range and what was expected, based on the patient¿s status.The issue was solved by replacing the catheter.No further information was available regarding if there was an error message displayed or any other details about this event.There was no patient injury and the patient was not treated according to the displayed values.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• 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: lynn thomas ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 9622616
• MDR Text Key: 188656258
• Report Number: 2015691-2020-10255
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K924452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62399257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG