FDA Adverse Event
Injury
Summary report: N
VENA SEAL CLOSURE SYSTEM
MDR report key: 15892113
·
Received December 1, 2022
Report
- Report Number
- 9612164-2022-04511
- Event Type
- Injury
- Date Received
- December 1, 2022
- Date of Event
- November 22, 2022
- Report Date
- December 1, 2022
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- PJQ
- PMA / PMN Number
- P140018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
A PATIENTS GREAT SAPHENOUS VEIN (GSV) WAS TREATED USING A VENASEAL CLOSURE SYSTEM. THE CATHETER WAS NOT FLUSHED PRIOR TO USE. THE IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR INSERTION AND PLACEMENT. COMPRESSION WAS NOT USED. THE SFJ WAS BENT AND TREATMENT WAS PERFORMED AT A DISTANCE OF 5CM OR MORE FROM THE SFJ. IT WAS REPORTED DURING THE FOLLOW-UP ONE WEEK LATER THAT THE PATIENTS EDEMA BECAME SEVERE ON THE TREATED FOOT. NO PAIN. DVT IN THE DEEP VEIN AROUND THE ABDOMEN AND MULTIPLE DVTS WERE SCATTERED AROUND THE KNEE AREA. THE PATIENT WAS URGENTLY HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2770954 | VENA SEAL CLOSURE SYSTEM | AGENT, OCCLUDING, VASCULAR, PERMANENT | PJQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Hospitalization |