MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 131F7J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Device was discarded by hospital staff as they believed there was no malfunction with the device.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The lot number was not provided thus a device history record was not reviewed.No corrective actions will be taken at this time.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 the patient suffered from shock during use of a swan ganz thermodilution catheter, oximetry central venous catheter, percutaneous cardiopulmonary support, and intra aortic balloon pump.The patient recovered from shock on the same day.The customer suspected that shock occurred due to latex allergy.Therefore, they made an inquiry whether the latex is used for the catheters.The sales rep responded to the customer that latex is used for the balloon of 131f7j.Further information including details of shock, how the patient was treated after shock or presence of a latex allergy was unable to be obtained.Patient demographic information was requested but unavailable.The customer stated that there was no malfunction with the ew catheters for this event.The device was discarded at the hospital since there was no malfunction.

• Brand Name: SWAN GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18365522
• MDR Text Key: 331005731
• Report Number: 2015691-2023-18585
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K810124
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 131F7J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other