FDA Adverse Event
Malfunction
Summary report: N
GEMINI
MDR report key: 19677085
·
Received July 4, 2024
Report
- Report Number
- 2124215-2024-40634
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- June 14, 2024
- Report Date
- July 4, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- UDI-DI
- 08714729074311
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF STONE INSIDE THE BASKET WHEN IT DID NOT OPEN.
Description of Event or Problem · 0
IT WAS REPORTED THAT A MINI-GEMINI BASKET WAS USED DURING A LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BASKET AND GRABBED THE STONE; HOWEVER, WHEN THEY TRIED TO RETRACT AND OPEN THE BASKET IT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256182 | GEMINI | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | BOSTON SCIENTIFIC CORPORATION | M0063303070 | 0033214174 | 08714729074311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |