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

Model Number 777F8

Device Problems Material Fragmentation (1261); No Device Output (1435)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one swan ganz catheter, model 777f8.The report of unable to populate cardiac output cardiac index was confirmed.When the catheter was running cco on hemosphere monitor, fault co check thermal filament position error massage was shown and stopped cco monitoring.Additionally, the balloon latex appeared deteriorated and multiple cracks were evident on the balloon latex.Leakage was observed through cracks on the deteriorated balloon latex and the balloon edges did not appear to match up at the cracks.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone and appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.No visible damage was observed from catheter body and syringe.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.

Event Description

It was reported that a swan ganz model 777f8, lot 64552372, populated a check thermal filament error.There was no allegation of patient injury noted.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.There are manufacturing controls to avoid potential root causes related the additional failure modes of balloon latex deterioration and connector error in eeprom.A product risk assessment addresses the catheter general confirmed error message failure mode, and a capa to address this issue is currently in its implementation phase.The capa investigation concluded that the root cause is due to a manufacturing issue.As a result, edwards fca reference number 175 was voluntarily initiated instructing customers that if a thermal filament error message is displayed at the start of patient monitoring, continuous cardiac output will not function and they may utilize intermittent bolus thermodilution cardiac output, aka ico, or replace the device.

• 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: 16492235
• MDR Text Key: 310994872
• Report Number: 2015691-2023-11296
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240808(11)220809(10)64552372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64552372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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