AXIOS
Report
- Report Number
- 3005099803-2024-06845
- Event Type
- Malfunction
- Date Received
- January 8, 2025
- Date of Event
- December 10, 2024
- Report Date
- April 22, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729904595
- PMA / PMN Number
- K233318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE F1001 CAPTURES THE REPORTABLE EVENT OF PROCEDURE ABORTED OR CANCELLED. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE TIP OF THE NOSECONE HAD EVIDENCE OF CAUTERY. THE ELECTRICAL INSPECTION RELATED TO THE CONTINUITY BETWEEN THE RF CONNECTOR AND DISTAL RF ELECTRODE WAS PERFORMED AND NO ISSUES WERE NOTED. ALSO, THE DEVICE WAS CONNECTED TO THE ERBE, AND BUBBLES WAS SEEN IN THE SALINE SOLUTION THAT IS EVIDENCE THAT THE TIP IS WORKING PROPERLY. AN IMAGE RECEIVED FROM THE CUSTOMER WHICH WAS ANALYZED AND SHOWED THE DEVICE INSIDE THE PATIENT. THERE WERE NO DAMAGES NOTED ON THE RETURNED DEVICE. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF CAUTERY FAILURE TO DELIVER ENERGY AS THE RETURNED DEVICE PASSED ALL THE ELECTRICAL AND FUNCTIONAL INSPECTIONS. THERE WAS NO EVIDENCE FOUND THAT THE CAUTERY DID NOT DELIVER ENERGY. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED.
BLOCK D2B: PRODUCT CODE : KNS, PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE F1001 CAPTURES THE REPORTABLE EVENT OF PROCEDURE ABORTED OR CANCELLED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE GALLBLADDER TO TREAT A CHOLITHIASIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACTIVATE THE CAUTERY TO PUNCTURE THE DUODENUM TO PLACE ACCESS INTO THE GALLBLADDER VIA ES IMAGE. WHEN THE ENDOSCOPIC VIEW WAS REGAINED, IT WAS SEEN THAT THE AXIOS CATHETER WOULD NOT PUNCTURE THE DUODENAL WALL. THE PROCEDURE WAS ABORTED AS A RESULT OF THIS EVENT. TO COMPLETE THE PROCEDURE, THE PATIENT WAS SENT FOR A GALLBLADDER REMOVAL THAT WAS PERFORMED ON (B)(6) 2024. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE GALLBLADDER TO TREAT A CHOLITHIASIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACTIVATE THE CAUTERY TO PUNCTURE THE DUODENUM TO PLACE ACCESS INTO THE GALLBLADDER VIA ES IMAGE. WHEN THE ENDOSCOPIC VIEW WAS REGAINED, IT WAS SEEN THAT THE AXIOS CATHETER WOULD NOT PUNCTURE THE DUODENAL WALL. THE PROCEDURE WAS ABORTED AS A RESULT OF THIS EVENT. TO COMPLETE THE PROCEDURE, THE PATIENT WAS SENT FOR A GALLBLADDER REMOVAL THAT WAS PERFORMED ON (B)(6) 2024. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235099 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553650 | 0034101934 | 08714729904595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |