FDA Adverse Event
Malfunction
Summary report: N
SENSOR
MDR report key: 20788466
·
Received November 26, 2024
Report
- Report Number
- 2124215-2024-74218
- Event Type
- Malfunction
- Date Received
- November 26, 2024
- Date of Event
- September 12, 2024
- Report Date
- November 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EZB
- UDI-DI
- 08714729257325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF EVALUATION RESULT CODE C070601 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF SLEEVE DETACHED.
Description of Event or Problem · 0
IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY WITH URETEROSCOPY PROCEDURE, THE SENSOR WIRE WAS GOING TO BE USED. UPON UNPACKING, IT WAS NOTICED THAT THE BACK END OF THE GUIDEWIRE WAS FRAYED OUT OF THE HOUSING, AND IT WAS REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSOR WIRE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844149 | SENSOR | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | BOSTON SCIENTIFIC CORPORATION | M0066703101 | 0034592551 | 08714729257325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |