TOTAL ABSCESSION DRAINAGE CATHETER
Received Aug 28, 2013 · Event occurred Aug 9, 2013
Report 1319211-2013-00104 · MDR key 3393350
Device
Product problems
- Fracture
- Occlusion Within Device
- Defective Device
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THERE WAS NO PERMANENT HARM OR INJURY TO THE PT DUE TO THIS EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND PT WELL-BEING. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).
Description of Event or Problem
AS REPORTED ON (B)(4) 2013, A PT OF UNKNOWN AGE AND GENDER PRESENTED FOR SUCCESSFUL DRAINAGE CATHETER PLACEMENT ON (B)(6) 2013. THE FOLLOWING DAY, (B)(6) 2013, IT WAS REPORTED THE CATHETER WAS NOT DRAINING AS INTENDED, AS THE BALL ON THE TIP OF THE CATHETER HAD FRACTURED OFF INTO THE DRAIN AND OCCLUDED THE CATHETER. THERE WAS NO REPORT OF PERMANENT HARM OF INJURY TO THE PT DUE TO THIS EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND PT WELL-BEING. IT IS UNKNOWN IF THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN THE DEFECTIVE DEVICE FOR EVALUATION.