AXIOS
Report
- Report Number
- 3005099803-2024-06680
- Event Type
- Injury
- Date Received
- December 26, 2024
- Date of Event
- December 3, 2024
- Report Date
- January 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 00191506008093
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2024. BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K203132, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILED TO DEPLOY FOR BILIARY INDICATION.
BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K203132, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILED TO DEPLOY FOR BILIARY INDICATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE HANDLE DID NOT UNLOCK, WHICH RESULTED IN THE STENT BEING UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED FOR BILIARY DRAINAGE. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2024*** IT WAS REPORTED THAT THE STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE BILE DUCT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE HANDLE DID NOT UNLOCK, WHICH RESULTED IN THE STENT BEING UNABLE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED FOR BILIARY DRAINAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2494499 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553690 | 0031806978 | 00191506008093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |