MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

Model Number 777F8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that swan ganz catheter model 777f8, lot 64410911, that during the procedure, the svo2 numbers were reading at half of what the clinician thought it should be.Troubleshooting was to get a venous gas and to do an in vivo calibration for correct numbers.The catheter was not available as it was discarded by facility and a new swan was used.There was no injury to the patient.

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.Upon the device history record review results, a supplemental report will be sent.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

It was originally reported that the customer experienced 5 failed devices, for which each device was previously reported under mdr numbers 2015691 2022 10041, 2015691 2022 10046, 2015691 2022 10047, 2015691 2022 10048, and 2015691 2022 10049.It was clarified that the customer experienced several device failures, but the failures did not occur during the same event.Additionally, only one date of occurrence is known, while the exact number of occurrences and dates for the other reported failures are unknown.Therefore, the previous reports listed above were reported in error, as the customer report of 5 failed devices referred to the quantity of remaining stock they pulled from their shelves and not to the number of occurrences they experienced.Awareness of these facts was not known until notification from the edwards product evaluation lab indicated that the returned devices were sealed units returned for loss of confidence.A new mdr capturing the events for the unknown dates was submitted under mdr number 2015691 2023 10432.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• 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: 15992493
• MDR Text Key: 306449264
• Report Number: 2015691-2022-10047
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240524(11)220525(10)64410911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64410911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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