FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ VIP
MDR report key: 24456187
·
Received February 26, 2026
Report
- Report Number
- 2015691-2026-11408
- Event Type
- Malfunction
- Date Received
- February 26, 2026
- Date of Event
- January 15, 2026
- Report Date
- February 26, 2026
- Manufacturer
- EDWARDS LIFESCIENCES DR
- Product Code
- DYG
- UDI-DI
- 00690103218282
- PMA / PMN Number
- K160084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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. ADDITIONAL D2B: PRODUCT CODE: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL G4: 510K: K231248.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SWAN-GANZ THERMODILUTION CATHETER WAS PRODUCING QUESTIONABLE NUMBERS FOR CARDIAC INDEX. THE NUMBERS ARE NOT MATCHING A CALCULATION USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154945 | SWAN-GANZ VIP | CATHETER, FLOW DIRECTED | DYG | EDWARDS LIFESCIENCES DR | 831F75P | 66591113 | 00690103218282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |