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

Model Number 777F8

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a balloon of a swan ganz catheter came off while inside the patient.Clinician initially had difficulty placing the catheter.When the catheter was pulled, the balloon was gone.Per follow up, the physician placed the catheter in anesthesia.Missing balloon was unable to be located.Device is being held with risk management.Additional information and return of device is unknown.

Manufacturer Narrative

The device was not returned for evaluation.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.Further evaluation regarding related quality issues is under investigation.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.

Manufacturer Narrative

Additional information was received from physician.It was reported that the catheter was used during a coronary case with a robotic mitral valve.Catheter was initially inserted by routine insertion.A cortis was successfully inserted and the catheter had no issues during device prep, but physician noticed that the ij was narrow.Swan was floated into the left side with tee.Catheter was not seen entering the right atrium and ventricle, so two to three attempts to float was made.When catheter was rotated, it felt tight in the introducer.Catheter was withdrawn and checked for issues.Balloon was present and no issues were noted.However, placement issue continued.On the second withdrawal of the catheter, the balloon was missing.No inflation resistance, arrhythmia, lung issue, sat change occurred.An xray was used to try to locate the balloon and introducer was checked.No balloon was visualized and no intervention to retrieve balloon was conducted.Surgeon took the wait and see approach in locating the balloon.Surgeon noted that the balloon may have came out and been caught in the sheets.Catheter was exchanged and inserted in the existing introducer to resolve the issue.Family and patient were made aware of the incident.Patient outcome was good.Corrections to the h6 codes health effect impact code and health effect clinical code were made.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.

Manufacturer Narrative

Two images, provided by customer, were evaluated.Packaging of 777f8 from lot 64918620 and a swan catheter were in the images.Catheter balloon appeared to be torn from distal and proximal bonds.The central area of balloon latex was missing and not observed in the images.Residual latex were visible from distal and proximal balloon bonds.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.

Manufacturer Narrative

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.

• Brand Name: SWAN GANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17572519
• MDR Text Key: 321430140
• Report Number: 2015691-2023-15315
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)250315(11)230316(10)64918620
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2023

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 Model Number: 777F8
• Device Lot Number: 64918620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 08/25/2023; 09/22/2023
• Supplement Dates FDA Received: 09/06/2023; 09/14/2023; 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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