ARROW CONTINUOUS NERVE BLOCK KIT

Description of Event or Problem

COMPLAINT ALLEGES THAT THE CLINICIAN WAS UNABLE TO VIEW THE TIP OF THE CATHETER DURING THE REMOVAL OF THE PRODUCT.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED ONE 19 GA STIMUCATH FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND ADHESIVE RESIDUE COULD BE SEEN ON THE CATHETER BODY EXTERIOR. THERE WAS NO VISIBLE EXPOSED COIL AT THE DISTAL TIP. THE EXPOSED COIL AT THE PROXIMAL END APPEARED TO BE DAMAGED AND THE COILS AT THE MOST PROXIMAL END APPEARED TO BE SEPARATED. THE PROXIMAL WELD WAS INTACT AND THE SAFETY RIBBON WAS PRESENT. MICROSCOPIC EXAMINATION INTO THE DISTAL END DID NOT REVEAL THE PRESENCE OF THE DISTAL TIP. WITH THE EXTRUSION REMOVED, IT COULD BE SEEN THAT THE DISTAL TIP WAS INTACT AND THE DISTAL BALL WELD WAS PRESENT. A WIRE WAS INSERTED INTO THE DISTAL END OF THE CATHETER AND IT WAS FOUND THAT THE DISTAL METAL TIP WAS RETRACTED APPROXIMATELY 8MM, WHICH IS WITHIN SPECIFICATIONS. THE REPORTED COMPLAINT OF THE TIP OF THE CATHETER NOT VISIBLE DURING REMOVAL WAS CONFIRMED BASED ON THE CONDITION OF THE SAMPLE RECEIVED. THE RETURNED CATHETER WAS RECEIVED WITH THE DISTAL TIP RETRACTED APPROXIMATELY 2MM INTO THE EXTRUSION. THE EXPOSED COIL AT THE DISTAL END WAS FOUND TO BE OUT OF SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT IS MANUFACTURING RELATED. THIS CATHETER'S APPEARANCE WITH THE MOVEMENT OF THE EXTRUSION OVER THE GUIDE WIRE IS SIMILAR TO THE APPEARANCE OF SAMPLES BEING INVESTIGATED UNDER CAPA (B)(4) FOR OUT OF SPECIFICATION EXPOSED WIRE LENGTH OF ANESTHESIA CATHETERS. THEREFORE, CAPA (B)(4) WILL ALSO INVESTIGATE THIS COMPLAINT ISSUE SINCE THE TWO APPEAR TO BE RELATED.