FDA Adverse Event
Malfunction
Summary report: N
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
MDR report key: 17257308
·
Received July 5, 2023
Report
- Report Number
- 3001845648-2023-00532
- Event Type
- Malfunction
- Date Received
- July 5, 2023
- Date of Event
- April 28, 2023
- Report Date
- June 6, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002506234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PMA 510K # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Description of Event or Problem · 0
UPON DEPLOYING BILATERAL STENT, THE DEPLOYMENT DEVICE BROKE WITHIN THE SCOPE (395986 )-. THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE FROM THE SCOPE WITH A BIOPSY FORCEP. THE STENT WAS ABLE TO BE PLACED IN THE TARGET LOCATION. NO HARM TO PATIENT AND NO NEED FOR ADDITIONAL/INTERVENTIONAL PROCEDURES. THIS FILE WILL CAPTURE THE USER ERROR OF NOT DEPLOYING THE SIDE-BY-SIDE STENTS SIMULTANEOUSLY AS PER IFU. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1931356 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50623 | C2024125 | 10827002506234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |