SPYGLASS RETRIEVAL BASKET

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER BASKET WAS USED IN THE PANCREAS FOR STONE RETRIEVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO EXTRACT A PANCREATIC STONE. THE BASKET WAS PLACED AROUND THE STONE, BUT THE STONE GOT STUCK IN THE PANCREATIC DUCT, LIKELY DUE TO THE PATIENT'S CHRONIC PANCREATITIS. THE BASKET THEN BECAME STUCK, AND APPROXIMATELY 15CM OF THE WIRE WAS EXPOSED IN THE DUODENUM. AS A RESULT, THE PROCEDURE WAS CANCELLED WITH THE PATIENT UNDER SEDATION OR ANESTHESIA. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT AND EXPERIENCED NO COMPLICATIONS. AN ANTICIPATED EXPLANT OR REVISION WAS INITIALLY SCHEDULED FOR (B)(6) 2026, BUT IT WAS RESCHEDULED TO (B)(6) 2026, DUE TO A SHORTAGE OF ANESTHESIA PERSONNEL. ULTIMATELY, THE SECOND ERCP WAS PERFORMED ON (B)(6) 2026. THE PHYSICIAN USED A SPYGLASS SYSTEM TO ASSESS THE SITUATION AND CONFIRMED THAT THE BASKET WAS INDEED STUCK IN THE PANCREATIC DUCT. LASER LITHOTRIPSY WAS THEN USED TO FRAGMENT THE PANCREATIC STONE. AS A RESULT, TWO OF THE BASKET'S METAL THREADS WERE CUT BY THE LASER, WHICH ALLOWED THE BASKET TO BE REMOVED MORE EASILY. AFTER THE PROCEDURE, TWO PLASTIC STENTS WERE PLACED IN THE PANCREATIC DUCT TO SUPPORT DOWNSTREAM CONTROL. THE PATIENT'S OVERALL CONDITION WAS GOOD, AND DISCHARGE WAS EXPECTED THE FOLLOWING DAY.

Additional Manufacturer Narrative

BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHMENT OF DEVICE OR DEVICE COMPONENT. IMDRF PATIENT CODE E2008 CAPTURES THE REPORTABLE EVENT OF UNRETRIEVED DEVICE FRAGMENTS. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.