SPYGLASS DIRECT VISUALIZATION SYSTEM

Additional Manufacturer Narrative

WORKING CHANNEL EVALUATION FOUND THAT THE SPYBITE PASSED THROUGH THE WORKING CHANNEL AND EXITED THE DISTAL END WITH NO ISSUES. THE RETURNED DEVICE WAS FOUND TO HAVE A SMALL PIECE OF PLASTIC, WHICH DID NOT COME FROM THE SPYSCOPE DEVICE AND IT IS UNKNOWN AS TO WHERE IT ORIGINATED FROM. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED; THEREFORE, THE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE WAS INSPECTED AND TESTED PRIOR TO USE WITH NO ISSUES NOTED. A NON-BSC LASER DEVICE WAS BEING USED IN CONJUNCTION WITH THE SPYSCOPE ACCESS & DELIVERY CATHETER TO BREAK A STONE. DIFFICULTY WAS ENCOUNTERED WHEN ADVANCING THE NON-BSC LASER DEVICE THROUGH THE SPYSCOPE. AFTER MANIPULATING THE LASER SEVERAL TIMES, THEY FOUND A ¿LITTLE PIECE OF PLASTIC CAME OUT OF THE SHEATH OF THE SCOPE¿ AND FELL INTO THE PATIENT WHICH WAS RETRIEVED USING BIOPSY FORCEPS. A SECOND SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED WITH THE LASER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE WAS INSPECTED AND TESTED PRIOR TO USE WITH NO ISSUES NOTED. A NON-BSC LASER DEVICE WAS BEING USED IN CONJUNCTION WITH THE SPYSCOPE ACCESS & DELIVERY CATHETER TO BREAK A STONE. DIFFICULTY WAS ENCOUNTERED WHEN ADVANCING THE NON-BSC LASER DEVICE THROUGH THE SPYSCOPE. AFTER MANIPULATING THE LASER SEVERAL TIMES, THEY FOUND A ¿LITTLE PIECE OF PLASTIC CAME OUT OF THE SHEATH OF THE SCOPE¿ AND FELL INTO THE PATIENT WHICH WAS RETRIEVED USING BIOPSY FORCEPS. A SECOND SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED WITH THE LASER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.