FDA Adverse Event
Malfunction
Summary report: N
NAVIGATOR HD
MDR report key: 19480717
·
Received June 6, 2024
Report
- Report Number
- 2124215-2024-34360
- Event Type
- Malfunction
- Date Received
- June 6, 2024
- Date of Event
- May 9, 2024
- Report Date
- June 6, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FED
- UDI-DI
- 08714729837992
- PMA / PMN Number
- K140323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK E1: FACILITY ADDRESS: (B)(6). BLOCK H6: IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF INNER PACKAGE BROKEN.
Description of Event or Problem · 0
IT WAS REPORTED THAT NAVIGATOR ACCESS SHEATH DEVICE WAS TO BE USED DURING A URETEROFLEXIBLE HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE INNER PACKAGE WAS BROKEN, AND THE STERILE BARRIER WAS BREACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275153 | NAVIGATOR HD | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY | FED | BOSTON SCIENTIFIC CORPORATION | M0062502250 | 0030621123 | 08714729837992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |