CAPIO SLIM
Report
- Report Number
- 2124215-2025-89003
- Event Type
- Malfunction
- Date Received
- December 9, 2025
- Date of Event
- November 7, 2025
- Report Date
- February 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PWI
- UDI-DI
- 08714729842224
- PMA / PMN Number
- K172060
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF DEVICE MISFIRED.
BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF DEVICE MISFIRED.
IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-89001 FOR THE FIRST CAPIO SLIM DEVICE, AND 2124215-2025-89003 FOR THE SECOND CAPIO SLIM DEVICE.
IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-89001 FOR THE FIRST CAPIO SLIM DEVICE, AND 2124215-2025-89003 FOR THE SECOND CAPIO SLIM DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2721762 | CAPIO SLIM | SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH | PWI | BOSTON SCIENTIFIC CORPORATION | M0068318261 | 0036381047 | 08714729842224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |