FLEXIMA
Report
- Report Number
- 2124215-2025-80750
- Event Type
- Malfunction
- Date Received
- November 13, 2025
- Date of Event
- October 15, 2025
- Report Date
- December 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729323273
- PMA / PMN Number
- K944290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER FACILITY NAME: (B)(6).
(B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE DEVICE RETURNED WITH THE NEEDLE, THE 8F DILATOR, THE GUIDEWIRE, THE FLEXIBLE CANNULA AND THE TUBE CONNECTOR. THESE COMPONENTS RETURN IN GOOD CONDITION. THE METAL CANNULA RETURNED ASSEMBLED IN THE CATHETER; HOWEVER, IT IS KINKED. THERE IS NO EVIDENCE OF A DETACHMENT IN THE CATHETER, BUT THE LUER LOCK MALE FROM THE METAL CANNULA IS DETACHED THAT COULD BE RELATED TO WHAT THE CUSTOMER REPORTS BY "THE CATHETER WAS FRACTURED". THERE IS EVIDENCE OF LOCTITE IN THE CANNULA INDICATING THE MALE ADAPTOR WAS ATTACHED INITIALLY. THE METAL CANNULA WAS REMOVED FROM THE CATHETER, AND NO RESISTANCE WAS FELT WHEN REMOVING THE CANNULA, AND THE PIG TAIL DOES FORM CORRECTLY.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC BILIARY STENTING (PTBS) AND PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE CATHETER WAS FRACTURED AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC BILIARY STENTING (PTBS) AND PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE CATHETER WAS FRACTURED AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985308 | FLEXIMA | TUBE, DRAINAGE, SUPRAPUBIC | FGE | BOSTON SCIENTIFIC CORPORATION | 32095 | 0035278565 | 08714729323273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male |