FDA Adverse Event
Other
Summary report: N
VORTEX-AC WITH KIT
MDR report key: 251149
·
Received November 23, 1999
Report
- Report Number
- 1056436-1999-00206
- Event Type
- Other
- Date Received
- November 23, 1999
- Date of Event
- November 3, 1999
- Report Date
- November 9, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 11/09/1999, THE SURGEON INFORMED THE MFR'S (MFR.) SALES REPRESENTATIVE OF THE FOLLOWING: WHEN THE SURGEON CONNECTED THE CATHETER TO THE DEVICE AND SLID DOWN THE LOCKING RING, HE NOTICED THE SILICONE SIDES ON THE LOCKING RING WERE NOT LEVEL. HE REPEATED SEVERAL TIMES AND REPLACED THE DEVICE BODY WITH A NEW DEVICE BODY. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VORTEX-AC WITH KIT Implant | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 981001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |