SPYGLASS DISCOVER DIGITAL CONTROLLER
Received Oct 6, 2023 · Event occurred Sep 16, 2023
Report 3005099803-2023-05230 · MDR key 17885847
Device
Product problems
- Poor Quality Image
- Optical Problem
- Poor Quality Image
- Optical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND SERIAL NUMBER; THEREFORE THE UNIQUE IDENTIFIER (UDI) #, MANUFACTURE DATE, AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.
Description of Event or Problem
NOTE: THIS REPORT PERTAINS TO A SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER AND A SPY DISCOVER CONTROLLER WERE USED DURING A PERCUTANEOUS SPYGLASS PROCEDURE PERFORMED FOR THE TREATMENT OF STENOSIS ON (B)(6) 2023. DURING THE PROCEDURE, THE IMAGE FROM THE SPY DISCOVER CATHETER WAS LOST AT THE TIME OF ACCESS, THE IMAGE DISCONNECTS AND RECONNECTS. THEY TURNED ON AND OFF THE SPY DISCOVER CONTROLLER; HOWEVER, THE IMAGE PROBLEM PERSISTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.