SPYSCOPE DS II ACCESS AND DELIVERY CATHETER

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS DIGITAL CONTROLLER WAS INTENDED FOR USE WITH A SPYSCOPE DS II DEVICE IN AN ENDOSCOPIC PROCEDURE ON (b)(6)2026. DURING THE PROCEDURE, THE CONTROLLER BEGAN REBOOTING UNEXPECTEDLY AND SUBSEQUENTLY FAILED COMPLETELY, RESULTING IN LOSS OF THE VISUALIZATION. AFTER SWITCHING TO A SECOND SPYSCOPE DS II, THE SAME BEHAVIOR RECURRED. AS A RESULT, THE SYSTEM WAS NO LONGER AVAILABLE FOR THE PROCEDURE, AND THE DEVICE COULD NOT BE USED TO CONTINUE THE PROCEDURE AS INTENDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. BLOCK D4: DETAILED LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.