FDA Adverse Event
Death
Summary report: N
LEVEEN¿ COACCESS¿
MDR report key: 6794791
·
Received August 15, 2017
Report
- Report Number
- 2134265-2017-08471
- Event Type
- Death
- Date Received
- August 15, 2017
- Report Date
- August 7, 2017
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- GEI
- PMA / PMN Number
- K012315
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BALAGEAS ET AL. (2013). EUROPEAN JOURNAL OF RADIOLOGY. TEN-YEAR EXPERIENCE OF PERCUTANEOUS IMAGE-GUIDED RADIOFREQUENCY ABLATION OF MALIGNANT RENAL TUMORS IN HIGH-RISK PATIENTS. EUR RADIOL, 23, 1925-1932. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT POST RADIOFREQUENCY ABLATION PROCEDURE, ONE PATIENT DIED BECAUSE OF THERMAL INJURY OF THE DUODENUM AND PERFORATION 1 WEEK AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575929 | LEVEEN¿ COACCESS¿ | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M001262230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |