SPYGLASS DIRECT VISUALIZATION PROBE
Received Oct 29, 2008 · Event occurred Sep 26, 2008
Report 3005099803-2008-05576 · MDR key 1216232
Device
Product problems
- Normal
Patient
60 YR
- Microperforation(s)
- Improved patient condition
- Other (for use when an appropriate patient code cannot be identified)
- Hospitalization required
Narrative
Description of Event or Problem
NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED IN THIS PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2008-005577 FOR DETAILS REGARDING THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING A PROCEDURE USING A SPYGLASS DIRECT VISUALIZATION PROBE (MALE PATIENT WEIGHT IS UNKNOWN), FREE AIR WAS FOUND NEAR THE DIAPHRAGM; THERE WAS NO CONTRAST IN THIS SPACE. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH AN "ELEVATED WHITE COUNT," BUT WAS NOT FEVERISH. IT WAS FURTHER REPORTED THAT ADDITIONAL EVALUATION LED TO A BELIEF THAT A MICRO PERFORATION HAD OCCURRED AROUND THE SPHINCTEROTOMY SITE. THE PATIENT WAS IN ICU AND THEIR CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE AND IMPROVING."
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.