SPYGLASS DIRECT VISUALIZATION SYSTEM

Additional Manufacturer Narrative

ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, THE PATIENT IS OVER 18 YEARS OF AGE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE TOOK PLACE FOR BILIARY STONE EXTRACTION. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SPHINCTEROTOMY AND BALLOON DILATATION WERE PERFORMED. STONE EXTRACTION WAS ATTEMPTED WITH AN EXTRACTOR BALLOON AND LITHOTRIPSY BASKET. WHILE IRRIGATING WITH THE SPYGLASS CATHETER, THE PHYSICIAN NOTED THAT THE PATIENT'S ETOC LEVEL DROPPED SIGNIFICANTLY. AFTER 15 MINUTES OF ATTEMPTING TO USE THE SPYGLASS CATHETER, THE PROCEDURE WAS ABORTED WITH THE STONES REMAINING IN THE PATIENT. IT WAS REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS DURING THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED A STROKE APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE STROKE IS UNKNOWN. HE STATED THAT HE COULD NOT RULE OUT THAT AN AIR EMBOLISM LED TO THE PATIENT EXPERIENCING A STROKE POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED TO BE "FINE."

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE TOOK PLACE FOR BILIARY STONE EXTRACTION. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A SPHINCTEROTOMY AND BALLOON DILATATION WERE PERFORMED. STONE EXTRACTION WAS ATTEMPTED WITH AN EXTRACTOR BALLOON AND LITHOTRIPSY BASKET. WHILE IRRIGATING WITH THE SPYGLASS CATHETER, THE PHYSICIAN NOTED THAT THE PATIENT'S ETOC LEVEL DROPPED SIGNIFICANTLY. AFTER 15 MINUTES OF ATTEMPTING TO USE THE SPYGLASS CATHETER, THE PROCEDURE WAS ABORTED WITH THE STONES REMAINING IN THE PATIENT. IT WAS REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS DURING THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED A STROKE APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE STROKE IS UNKNOWN. HE STATED THAT HE COULD NOT RULE OUT THAT AN AIR EMBOLISM LED TO THE PATIENT EXPERIENCING A STROKE POST PROCEDURE. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED TO BE "FINE." UPDATED INFORMATION 06FEB2012. UNDER FLUOROSCOPIC VISUALIZATION, THERE WAS NOTED TO BE A "GAS BUBBLE" WHILE THE SPYGLASS CATHETER WAS WITHIN THE PATIENT. THE PATIENT WAS DESCRIBED AS STABLE POST PROCEDURE.