OUTBACK

Additional Manufacturer Narrative

AS REPORTED, A RADIOPAQUE MARKER OF THE OUTBACK ELITE 120CM CATHETER BROKE OFF INSIDE A PATIENT DURING SURGERY. THE EVENT WAS REPORTED BY THE PATIENT TO THE MRI TEAM AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER FOR THIS PRODUCT IS UNKNOWN. THE REPORTED ¿MARKER BAND (OUTBACK) ¿ DISLODGED¿ COULD NOT BE SUBSTANTIATED. THE INVESTIGATION WAS LIMITED BY THE LACK OF A RETURNED DEVICE, SUPPORTING IMAGES, AND LOT INFORMATION; THEREFORE, THE REPORTED CONDITION AND ITS CAUSE COULD NOT BE FOUND. USERS ARE INSTRUCTED TO INSPECT THE DEVICE FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE, AND DEVICES EXHIBITING DAMAGE ARE NOT INTENDED TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCT LABELING TO INFORM USERS OF POTENTIAL RISKS. HOWEVER, DUE TO THE LIMITED INFORMATION AVAILABLE FOR THIS COMPLAINT, INCLUDING THE ABSENCE OF A RETURNED DEVICE, SUPPORTING IMAGES, OR PROCEDURAL DETAILS, USER COMPLIANCE WITH THE INSTRUCTIONS FOR USE COULD NOT BE ASSESSED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THE REPORTED EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS; THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AS REPORTED, A RADIOPAQUE MARKER OF THE OUTBACK ELITE 120CM CATHETER BROKE OFF INSIDE A PATIENT DURING SURGERY. THE EVENT WAS REPORTED BY THE PATIENT TO THE MRI TEAM AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

Description of Event or Problem

AS REPORTED, A RADIOPAQUE MARKER OF THE OUTBACK ELITE 120CM CATHETER BROKE OFF INSIDE A PATIENT DURING SURGERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.