SPYGLASS RETRIEVAL BASKET

Additional Manufacturer Narrative

PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE BRAND NAME, UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4).

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO A SPYBASKET, TWO SPYSCOPE DS II ACCESS, & AUTOLITH TOUCH EHL PROBES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE BILIARY TRACT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE IN THE PATIENT'S BILIARY TRACT USING THE AUTOLITH PROBE TO BREAK UP THE STONES, THERE WAS INTERFERENCE WITH THE IMAGE ON THE MONITOR. AFTER A FEW MOMENTS THE INTERFERENCE SUBSIDED AND AN ATTEMPT WAS MADE TO INSERT THE SPYGLASS RETRIEVAL BASKET, BUT IT DID NOT PASS THROUGH THE WORKING CHANNEL. IT WAS ABANDONED AFTER SEVERAL ATTEMPTS. THE AUTOLITH PROBE ALSO BEGAN TO PRESENT RESISTANCE WHEN PASSING THROUGH THE WORKING CHANNEL. AROUND THE THIRTIETH HOUR OF THE PROCEDURE, THE TRANSMISSION WAS INTERRUPTED ON THE SCREEN MONITOR AND ONLY THE THREE GRAY DOTS INDICATING TIMEOUT WERE VISIBLE. FROM THAT MOMENT ON, THE IMAGE WAS COMPLETELY LOST. A SECOND SPYSCOPE WAS CONNECTED BUT DID NOT TRANSMIT ANY IMAGE. AFTER A FEW TROUBLESHOOTING, ALTERNATING THE SPYSCOPES THE IMAGES WERE NOT RESTORED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.