ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2024-00296
- Event Type
- Malfunction
- Date Received
- June 26, 2024
- Date of Event
- March 13, 2024
- Report Date
- April 16, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K163018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K163018. A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING RECEIPT OF CONFIRMATION OF THE DATE AWARE (DATE ANY COOK EMPLOYEE BECAME AWARE OF THIS OCCURRENCE). DATE AWARE CONFIRMED TO BE 18-MAR-2024. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K163018 A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING UPDATES TO A AND G CODES, REFLECTING USER ERROR. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE EMAIL FROM COMPLAINTS INVESTIGATION TEAM ON 19-MAR-25 THAT THERE WAS A USE ERROR WITH NO DEVICE MALFUNCTION IDENTIFIED AND THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT.
DESCRIPTION OF EVENT: WHEN DR. KIM DEPLOYED ZILVER STENT, THE ZILVER STENT WAS PUSHED DOWN THE STRICTURE. SO DR.KIM REMOVED STENT AND DEPLOYED ANOTHER ZILVER AGAIN. PATIENT OUTCOME: 1.1.1 WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? N/A.
A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING RECEIPT OF CONFIRMATION OF THE DATE AWARE (DATE ANY COOK EMPLOYEE BECAME AWARE OF THIS OCCURRENCE). DATE AWARE CONFIRMED TO BE 18-MAR-2024.
ADDITIONAL FILE BEING OPENED FOR DEVICE MALFUNCTION ((B)(4). FOLLOWING A RETROSPECTIVE REVIEW ON 18DEC2024, ON MDR REPORTS SUBMITTED IT WAS NOTED THAT THE IMDRF CODES DID NOT REFLECT USE ERROR. CORRECTION MDR SCHEDULED TO UPDATE A CODE TO A2303 AND G CODE TO G07001.
SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE EMAIL FROM COMPLAINTS INVESTIGATION TEAM ON 19-MAR-25 THAT THERE WAS A USE ERROR WITH NO DEVICE MALFUNCTION IDENTIFIED AND THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. "NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625206 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |