MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ VIP; CATHETER, CONTINUOUS FLUSH

Model Number	782F75M
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.A device history record review was unable to be completed as the lot number is unknown.
Event or Problem Description
It was reported that there was a failure with this swan-ganz catheter (782f75m, lot number unknown).Per the sales representative, during a cabg procedure, after the patient came off the pump, the swan did not show a pa waveform.The anesthesiologist repositioned the swan back until a waveform appeared.When the surgery was completed, the anesthesiologist noticed that there was blood on the floor, but never found the reason.The patient was transferred to the icu and connected to the hemosphere.The temperature was never accurate reading 91 degrees.The swan would not wedge, even with advancement.When the swan was discontinued, the nurse noted that there was blood in the thermistor on the 70cc2 cable.There was no blood on the outside of the cable.There was a clot in the thermistor as well.There was no troubleshooting done.The non-edwards products involved were the introducer and arrow kit.There was no harm or injury to the patient.
Additional Manufacturer Narrative
The product lab received one 782f75m catheter with monoject limited volume syringe, 70cc2 cable, and non-edwards contamination shield.The reported issue of blood in the thermistor was confirmed.As received, blood was observed in thermistor connectors of the catheter and the 70cc2 cable.A 0.08 cut was found on the catheter body at approximately 30.5cm proximal from the tip.The cut entered the thermistor lumen.All through lumen were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.There was no other visible damage was observed from the catheter.All through lumens passed pressure test with lab dpt.The report of inaccurate temperature issue was unable to be evaluated due to the presence of the blood in the thermistor connector.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.
Additional Manufacturer Narrative
Udi related data quality updates only.The lot number for this device was not provided and is unknown, therefore, the full udi number is not available.The primary di number is: (b)(4).The following are additional product codes for this device: dqo catheter, intravascular, diagnostic.Dyg catheter, flow directed.Dqe catheter, oximeter, fiberoptic.The following is corrected data, as the original identification information sent in the initial report did not match the data submitted to the global unique device identification database (gudid): d1 brand name: swan-ganz vip.D2a common device name: catheter, continuous flush.D2b device product code: kra.

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17873823
• Report Number: 2015691-2023-16542
• Device Sequence Number: 8920193
• Product Code: KRA
• UDI-Device Identifier: 00690103197303
• UDI-Public: (01)00690103197303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K926450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 782F75M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 07/09/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/17/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown