ARROW CONTINUOUS NERVE BLOCK SET

Additional Manufacturer Narrative

(B)(4). THE CATHETER WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS FOUND TO BE SEPARATED. THE CUSTOMER INDICATED THAT THE CATHETER WAS IN USE FOR FOUR DAYS. THIS PRODUCT IS ONLY INDICATED FOR USE UP TO 72 HOURS. THE RETURNED CATHETER ALSO SHOWED SIGNS OF SEVERE STRETCHING AND THE CATHETER'S SAFETY RIBBON WAS SEPARATED WHICH INDICATES THAT THE CATHETER WAS PULLED ON WITH EXCESSIVE FORCE. NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BASED ON A LOT NUMBER FROM THE CUSTOMER SALES HISTORY. THERE WERE NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF DIFFICULT REMOVING THE CATHETER WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. BASED ON THE INFORMATION PROVIDED AND THE CONDITION OF THE SAMPLE RECEIVED, IT WAS DETERMINED THAT USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE STIMUCATH WAS IN PLACE FOR FOUR DAYS. AFTER COMPLETION OF THE THERAPY, DURING REMOVAL OF THE CATHETER IT SEEMS AS IF THE CATHETER WAS "FIRMLY GROWN" AND RESISTANCE WAS FELT. SOFT FORCE WAS APPLIED IN ORDER TO REMOVE THE CATHETER CAUSING THE CATHETER TO DISSOLVE INTO PARTS. THE CATHETER WAS REMOVED IN ITS ENTIRETY. NO PATIENT COMPLICATIONS. NO PATIENT INJURY REPORTED.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT THE STIMUCATH WAS IN PLACE FOR FOUR DAYS. AFTER COMPLETION OF THE THERAPY, DURING REMOVAL OF THE CATHETER, IT SEEMS AS IF THE CATHETER WAS "FIRMLY GROWN", AND RESISTANCE WAS FELT. SOFT FORCE WAS APPLIED IN ORDER TO REMOVE THE CATHETER CAUSING THE CATHETER TO DISSOLVE INTO PARTS. THE CATHETER WAS REMOVED IN ITS ENTIRETY. NO PATIENT COMPLICATIONS. NO PATIENT INJURY REPORTED

Additional Manufacturer Narrative

(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.