FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ VIP+
MDR report key: 24586880
·
Received March 12, 2026
Report
- Report Number
- 2015691-2026-13156
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Date of Event
- February 21, 2026
- Report Date
- May 26, 2026
- Manufacturer
- EDWARDS LIFESCIENCES PR
- Product Code
- DYG
- UDI-DI
- 00690103151756
- PMA / PMN Number
- K160084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL FDA PRODUCT CODES INCLUDE: DQE- CATHETER, OXIMETER, FIBEROPTIC DQO- CATHETER, INTRAVASCULAR, DIAGNOSTIC KRA- CATHETER, CONTINUOUS FLUSH. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING USE OF THE SWAN GANZ CATHETER THE CVP LINE BROKE OFF AT THE HUB. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568273 | SWAN-GANZ VIP+ | CATHETER, FLOW DIRECTED | DYG | EDWARDS LIFESCIENCES PR | 834F75 | 67075111 | 00690103151756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |