MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number	831F75P
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with this swan-ganz catheter, that the central venous pressure (cvp) and the pulmonary artery pressure (pap) readings were in reverse.There was no patient injury.
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, as well as the device history record review results when completed.
Additional Manufacturer Narrative
Two 831f75p catheters from the same lot number, in sealed packaging, were returned for examination.The customer stated he wanted both of them looked at due to loss of confidence.The reported issue of central venous pressure (cvp) and the pulmonary artery pressure (pap) readings being in reverse, was unable to be confirmed.As received, the catheter was found to be correctly identified and assembled.All through lumens were patent without any leakage or occlusion.A 10cc syringe was connected to each of the lumens being tested.Each associated port was covered with a fingertip, entire catheter was immersed in water and pressurized with air by compressing the syringe plunger.The balloon inflated with the returned syringe and immersed in water to check leakage.The balloon inflated clear and concentric inflated for five minutes.All through lumens passed the pressure test.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 part of this monthly review.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER
• Common Device Name: 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14364122
• Report Number: 2015691-2022-05668
• Device Sequence Number: 4155220
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)230405(11)210405(10)63707803
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2023
• Device Model Number: 831F75P
• Device Catalogue Number: 831F75P
• Device Lot Number: 63707803
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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
• Patient Sex: Unknown