EXPRESS SD RENAL/BILIARY
Report
- Report Number
- 2124215-2025-87848
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- November 18, 2025
- Report Date
- March 6, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729484844
- PMA / PMN Number
- K152607
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D2B - PRO CODE (PRODUCT CODE): FGE, NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. DEVICE EVALUATED BY MFR: THE EXPRESS SD WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE GUIDEWIRE LUMEN IS SEPARATED 133.2CM FROM THE HUB. THERE ARE MULTIPLE KINKS ON THE SHAFT. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THE DISTAL SECTION OF THE SHAFT, TIP, BALLOON, MARKER BAND, AND STENT ARE MISSING. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THERE IS DAMAGE TO THE DEVICE.
D2B - PRO CODE (PRODUCT CODE): FGE, NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006. H6 - DEVICE CODES: CORRECTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. DEVICE EVALUATED BY MFR: THE EXPRESS SD WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE GUIDEWIRE LUMEN IS SEPARATED 133.2CM FROM THE HUB. THERE ARE MULTIPLE KINKS ON THE SHAFT. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THE DISTAL SECTION OF THE SHAFT, TIP, BALLOON, MARKER BAND, AND STENT ARE MISSING. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THERE IS DAMAGE TO THE DEVICE.
D2B - PRO CODE (PRODUCT CODE): FGE, NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION.
IT WAS REPORTED THAT FRACTURE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE PROCEDURE, THE BALLOON AND STENT SHAFT WERE SEPARATED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.
IT WAS REPORTED THAT FRACTURE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE PROCEDURE, THE BALLOON AND STENT SHAFT WERE SEPARATED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.
IT WAS REPORTED THAT FRACTURE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE PROCEDURE, THE BALLOON AND STENT SHAFT WERE SEPARATED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2780676 | EXPRESS SD RENAL/BILIARY | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74937912618150 | 08714729484844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown |