NaviFlex? RX Delivery System

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PANCREATIC DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NAVIFLEX DEPLOYMENT KNOB WAS PULLED BUT WAS UNSUCCESSFUL, AND IT WAS NOTED THAT THE INNER CATHETER BROKE AND KINKED. THE PROCEDURE WAS COMPLETED USING AN EXTRACTOR PRO BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK B3:EVENT DATE HAS BEEN APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT, AS NO EVENT DATE WAS REPORTED.BLOCK D4, H4:THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.BLOCK H6:IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF GUIDE CATHETER BREAK.BLOCK H11:INVESTIGATION RESULTS:BOSTON SCIENTIFIC CORPORATION COULD NOT CONFIRM THE REPORTED EVENT OF CATHETER GUIDE BREAK. THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE AND WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT CONTRIBUTED TO THE EVENTS. DEVICE HISTORY RECORDS REVIEW:A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, A SHIP HISTORY REVIEW WAS PERFORMED TO IDENTIFY THE MOST PROBABLE LOTS AND A MANUFACTURING REVIEW OF THE MOST PROBABLE LOTS DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE EVENT. DEVICE TECHNICAL ANALYSIS:THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW:A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "CATHETER GUIDE BREAK" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION:BASED ON THE AVAILABLE INFORMATION, THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THE CAUSE OF REPORTED EVENT. WITHOUT PROPER EVALUATION OF THE COMPLAINT DEVICE, CAUSE NOT ESTABLISHED IS SELECTED AS THE INVESTIGATION CONCLUSION CODE.