FDA Adverse Event
Malfunction
Summary report: N
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
MDR report key: 15754695
·
Received November 8, 2022
Report
- Report Number
- 3005099803-2022-06562
- Event Type
- Malfunction
- Date Received
- November 8, 2022
- Date of Event
- September 23, 2022
- Report Date
- November 8, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K163272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REPORT SOURCE: MEDWATCH# 5112478. (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 20, 2022, THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH AXIOS STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE AXIOS STENT PREMATURELY DEPLOYED. THE STENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2548531 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0029796842 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |