FDA Adverse Event Malfunction Summary report: N

SWAN-GANZ VIP

MDR report key: 24537344 · Received March 6, 2026

Report

Report Number: 2015691-2026-12634
Event Type: Malfunction
Date Received: March 6, 2026
Date of Event: December 30, 2025
Report Date: May 19, 2026
Manufacturer: EDWARDS LIFESCIENCES, PR
Product Code: DYG
PMA / PMN Number: K160084
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. BECAUSE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER IS NOT AVAILABLE. 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. D2B. ADDITIONAL DEVICE PRODUCT CODE: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ G4. ADDITIONAL 510K: K231248.

Description of Event or Problem · 0

DURING USE, IT WAS REPORTED THAT THE SWAN GANZ VIP TD CATHETER HAD A FRACTURE OF THE PROXIMAL INJECTATE LUMEN WHERE THE WHITE CONNECTOR ENTERS THE BLUE TRANSPARENT TUBING. THE CATHETER AND TUBING WERE SECURED WITH A PULMONARY ARTERY CATHETER SECUREMENT DEVICE. IT WAS UNDETERMINED WHAT WAS INFUSING THROUGH THE PROXIMAL INJECTATE LUMEN AT THE TIME OF THE LEAKAGE. ON (B)(6) 2025, THE LEAKAGE WAS OBSERVED AND BLOOD WAS NOTED IN THE LINE, WHICH WAS THEN REMOVED AND REPLACED WITH ANOTHER SWAN GANZ CATHETER. NO PATIENT HARM WAS NOTED. THE CLINICAL RATIONALE FOR LONG-TERM MONITORING WITH THE CATHETER PLACED ON (B)(6) 2025 WAS HEMORRHAGIC SHOCK, ECMO CANNULATION, RE-EXPLORATION, AND IN-OR PEA ARREST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
474342	SWAN-GANZ VIP	CATHETER, FLOW DIRECTED	DYG	EDWARDS LIFESCIENCES, PR	831F75

Patients

Seq	Age	Sex	Outcome	Treatment
1