AXIOS?
Report
- Report Number
- 3005099803-2025-05941
- Event Type
- Malfunction
- Date Received
- November 10, 2025
- Date of Event
- October 17, 2025
- Report Date
- December 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729904588
- PMA / PMN Number
- K233318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B5 HAS BEEN UPDATED FOR THE ADDITIONAL INFORMATION RECEIVED (B)(6) 2025. BLOCK H6: IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF POOR VISIBILITY. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.
BLOCK H6: IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF POOR VISIBILITY. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, POOR VISIBILITY WAS OBSERVED. IT WAS REPORTED THAT THE DISTAL END OF THE DELIVERY SYSTEM COULD NOT BE VISUALIZED UNDER EUS. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. ***ADDITIONAL INFORMATION RECEIVED ON 21NOV2025: IT WAS LATER CONFIRMED THAT THE STENT WAS TO BE IMPLANTED IN THE GALL BLADDER TO TREAT ACUTE CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED GALLBLADDER DRAINAGE PROCEDURE ON (B)(6) 2025. IT WAS ALSO CONFIRMED THAT THE MALFUNCTION WAS OBSERVED POST-PUNCTURE. THEREFORE, MANTIS CLIPS WERE USED TO CLOSE THE PUNCTURE SITE. THE PROCEDURE WAS RESCHEDULED ON AN UNKNOWN DATE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, POOR VISIBILITY WAS OBSERVED. IT WAS REPORTED THAT THE DISTAL END OF THE DELIVERY SYSTEM COULD NOT BE VISUALIZED UNDER ENDOSCOPIC ULTRASOUND (EUS). AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1927388 | AXIOS? | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553640 | 0036799314 | 08714729904588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |