MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ VIP PLUS TRI-LUMEN; CATHETER, FLOW DIRECTED

Model Number 834F75

Device Problem Difficult to Remove (1528)

Patient Problem Arrhythmia (1721)

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with an (b)(6) swan-ganz catheter.The swan-ganz catheter was inserted intraoperatively prior to the start of open-heart bypass surgery.During the surgery closing phase, the anesthesiologist noticed that the pa pressures were not adequate.The case ended and the patient was transported to the intensive care unit (icu).In the icu, unsuccessful attempts were made to refloat the catheter.The patient returned to surgery for the catheter removal.In the post op icu, the catheter was not reading properly.The surgeon and anesthesiologist made attempts to remove and refloat the catheter.They could not completely pull the catheter out of the cordis sheath into the sterile sleeve.Each time it caused hemodynamic instability requiring inotropic and vasoactive support.The patient returned to surgery the same day for exploration under general anesthesia to remove the catheter.The surgeon decided to go on cardiopulmonary bypass to open the heart and determine where exactly the catheter was snagged.It was found that the catheter was in a knot and attached to the tricuspid valve.The catheter was able to be successfully removed from the tissue.The patient was weaned off bypass, the sternum closed, and the patient was transferred to icu.The device is not available for return.

Manufacturer Narrative

The device will not be returned for evaluation as it was discarded at the facility.Without the 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.A device history record review was unable to be completed as the lot number is unknown.An engineering evaluation was 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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text: device not returned.

• Brand Name: SWAN-GANZ VIP PLUS TRI-LUMEN
• Type of Device: 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; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17509670
• MDR Text Key: 320909838
• Report Number: 2015691-2023-15174
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810352
• 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
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 834F75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG