TOTAL ABSCESSION GENERAL DRAINAGE CATHETER

Additional Manufacturer Narrative

RETURNED FOR EVALUATION WAS A 14FX30CM DRAINAGE CATHETER. A VISUAL REVIEW OF THE RETURNED DEVICE NOTED NO DEFECT OR DAMAGE. THE TIP WAS NOT DETACHED AS REPORTED. THE DEVICE MET ALL MANUFACTURING DIMENSIONAL SPECIFICATIONS FOR THIS PRODUCT. THERE WAS NO EVIDENCE OF MATERIAL STRETCHING AT THE SITE OF THE BREAK, NOR WERE THERE ANY OBVIOUS VISUAL INDICATIONS OF DAMAGE DURING MANUFACTURE THAT COULD HAVE LED TO COMPROMISED INTEGRITY. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF "THE DRAINAGE CATHETER TIP BROKE OFF" IS NOT CONFIRMED. THE SAMPLE RETURNED SHOWED NO SIGNS OF DAMAGE AND WAS FULLY INTACT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, FAILURE MODE IS CONSISTENT WITH MATERIAL BREAKDOWN DUE TO EXPOSURE TO AN INCOMPATIBLE SUBSTANCE, POSSIBLY ALCOHOL. LABELING REVIEW: A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE PACKAGING LOTS AND ALL COMPONENT LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, STATES: ""WARNINGS: DO NOT USE THIS CATHETER WITH ALCOHOL. WHERE LONG-TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 90 DAYS. THIS CATHETER SHOULD BE EVALUATED BY THE PHYSICIAN ON OR BEFORE 90 DAYS POST PLACEMENT." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT # (B)(4).

Description of Event or Problem

DRAINAGE CATHETER #1- THE PATIENT HAD A14F DRAINAGE CATHETER WITH LOCKING PIGTAIL SUCCESSFULLY PLACED FOR NECROTIC COLLECTION IN PATIENT WITH PANCREATITIS. APPROXIMATELY ONE WEEK AFTER PLACEMENT, IT WAS NOTED THE CATHETER WAS NOT DRAINING AS INTENDED. CT IMAGES CONFIRMED THE PIGTAIL INSIDE THE POCKET AND THE SHAFT HAD DETACHED/BROKEN. IT WAS DETERMINED TO REMOVE THE CATHETER AND REPLACE WITH 2 NEW DRAINAGE CATHETERS. AFTER SOME WEEKS, ONE OF THE NEWLY PLACED CATHETERS DIDN'T PRODUCE AND THE SAME ISSUE OCCURRED, THE PIGTAIL IN THE POCKET AND NO CONNECTION WITH THE SHAFT. (THIS DEVICE WILL BE REPORTED ON MEDWATCH 1319211-2019-00041). THE FRACTURED PIECES WERE NOT RETRIEVED, AND THE PATIENT WAS SCHEDULED FOR A PROCEDURE TO REMOVE THE FRAGMENTS AT A LATER DATE. IT WAS INDICATED THAT THE PIGTAIL TIPS ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.