SPYGLASS RETRIEVAL BASKET

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE CYSTIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BASKET WITH THE STONE INSIDE, THE STONE IN THE SPYBASKET WOULD NOT RELEASE FROM THE CYSTIC DUCT. ADDITIONALLY, THE SPYBASKET HANDLE BROKE DUE TO MANIPULATION BY THE NURSE. THE HANDLE WAS MANUALLY CUT AND THE SPYSCOPE WAS REMOVED FROM THE BILE DUCT. A SOEHENDRA LITHOTRIPTER WAS USED TO BREAK THE STONE FROM THE SPYBASKET, ALLOWING THE SPYBASKET TO BE SAFELY REMOVED FROM THE CYSTIC DUCT AND THE BILE DUCT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN EHL PROBE. 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 FINE.