FDA Adverse Event
Injury
Summary report: N
INTRA-OPERATIVE POSITIONING SYSTEM (IOPS)
MDR report key: 23495806
·
Received November 7, 2025
Report
- Report Number
- 3012154226-2025-00004
- Event Type
- Injury
- Date Received
- November 7, 2025
- Date of Event
- October 27, 2025
- Report Date
- November 6, 2025
- Manufacturer
- CENTERLINE BIOMEDICAL
- Product Code
- DQK
- UDI-DI
- 00843152100002
- PMA / PMN Number
- K243842
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PROCEDURE WAS A FEVAR (PMEG) WITH LOWER EXTREMITY ARTERIAL ACCESS. SMA PRE-CANNULATED (QUICKLY), GRAFT PLACED, SMA FEN CANNULATED ALL WITH FLUOROSCOPY. STEERABLE SHEATH PLACED AT FENESTRATION WITH FLUOROSCOPY THEN IOPS USED TO CANNULATE LEFT RENAL ARTERY. REPEATED FOR RIGHT RENAL ARTERY. RIGHT RENAL ARTERY DISSECTED, RECANNULATED WITH GLIDEWIRE. TARGET VESSELS STENTED AND GRAFT FULLY DEPLOYED. NO FURTHER REPORTED EFFECTS ON PATIENT AS THE DISSECTION WAS FULLY TREATED BY THE STENT GRAFT ALREADY BEING PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180776 | INTRA-OPERATIVE POSITIONING SYSTEM (IOPS) | Computer, diagnostic, programmable | DQK | CENTERLINE BIOMEDICAL | MC-1 | N/A | 00843152100002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |