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

Model Number	831F75
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The devices were discarded by the hospital staff.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.No corrective actions will be taken at this time.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.
Event or Problem Description
It was reported that while using this swan ganz catheter the physician stated that he had a patient who developed a fever from the catheter.The initial reporter stated that she would like to know the chemical composition of the swan so that the patient can be tested for allergy and they can avoid the use of swan for those patients.This patient developed a fever every time he had a swan catheter inserted.The patient was in the hospital for 3 months and the swan was tested on him 4 times in the period of 3 months, where he developed a fever every time.All the infectious work-up is negative.There was no allegation made against the functionality of the swan and all 4 catheters were discarded.Patient demographics were requested but not available.

• Brand Name: SWAN GANZ CATHETER
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 13460105
• Report Number: 2015691-2022-03800
• Device Sequence Number: 5047650
• Product Code: DQE
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)230818(11)210818(10)63915199;(01)50690103003036(17)230818(11)210818(10)63915199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/18/2023
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Device Lot Number: 63915199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown