FDA Adverse Event
Malfunction
Summary report: N
SOLYX SIS SYSTEM
MDR report key: 20183666
·
Received September 10, 2024
Report
- Report Number
- 2124215-2024-54730
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- August 13, 2024
- Report Date
- September 10, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PAH
- UDI-DI
- 08714729774044
- PMA / PMN Number
- K081275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF FAILURE TO DEPLOY.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE PROCEDURE USING A SOLYX SIS SYSTEM DEVICE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE MESH USING THE DELIVERY DEVICE. ANOTHER DEVICE WAS OPENED, AND A SECOND DELIVERY DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2330414 | SOLYX SIS SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA | PAH | BOSTON SCIENTIFIC CORPORATION | M0068507000 | 0033327462 | 08714729774044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female |