FDA Adverse Event
Injury
Summary report: N
A4545 (5) PACK, THR-050-4F 5/BOX
MDR report key: 2885273
·
Received December 18, 2012
Report
- Report Number
- 2027111-2012-00401
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- December 10, 2012
- Report Date
- December 18, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- DXE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.
Description of Event or Problem · 1
FISTULA THROMBECTOMY - "THE THROMBECTOMY CATHETER TURNED ON TO ITS SELF AND TIED ITS SELF INTO A KNOT. MANY ATTEMPTS WERE MADE TO UNTIE THE KNOT. THESE ATTEMPTS WERE UNSUCCESSFUL. THE PROCEDURE WAS ABORTED AND THE PT SENT TO THE HOSPITAL TO HAVE THE THROMBECTOMY CATHETER REMOVED SURGICALLY." PT STATUS: "LOST FISTULA AND NOW HAS A TUNNELED CATHETER".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | A4545 (5) PACK, THR-050-4F 5/BOX | NONE | DXE | APPLIED MEDICAL | A4545 | 1176346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |