SPACEOAR VUE SYSTEM
Report
- Report Number
- 2124215-2025-80098
- Event Type
- Malfunction
- Date Received
- November 13, 2025
- Date of Event
- April 15, 2025
- Report Date
- April 10, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OVB
- UDI-DI
- 00850009803009
- PMA / PMN Number
- K182971
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: BLOCK B3, B5, D4 AND BLOCK E HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION. BLOCK G2 WAS CORRECTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR.
ADDITIONAL INFORMATION: BLOCK E1 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: BLOCK B3, B5, D4 AND BLOCK E HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION. BLOCK G2 WAS CORRECTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK D4:H4 THE EVENT WAS UNABLE TO PROVIDE THE LOT NUMBER/UPN OF THE DEVICE IMPLANTED. THEREFORE, THERE IS NOT INFORMATION RELATED WITH DEVICE MANUFACTURER DAY. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR.
IT WAS REPORTED THAT AFTER THE SPACEOAR PLACEMENT PROCEDURE, THE ACCOUNT REPORTED THAT THERE WAS A POTENTIAL INFILTRATION OF THE HYDROGEL IN THE RECTAL WALL. THERE WERE NO SERIOUS INJURIES REPORTED AS RESULTED OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 20NOV2025. IT WAS FURTHER REPORTED THAT THE MISPLACEMENT WAS NOTED PRIOR TO THE STEREOTACTIC BODY RADIATION THERAPY (SBRT), NO ACTIONS WERE TAKEN AT THIS TIME. THE RADIATION TREATMENT WAS DELIVERED IN FIVE FRACTIONS DURING MAY.
IT WAS REPORTED THAT AFTER THE SPACEOAR PLACEMENT PROCEDURE, THE ACCOUNT REPORTED THAT THERE WAS A POTENTIAL INFILTRATION OF THE HYDROGEL IN THE RECTAL WALL. THERE WERE NO SERIOUS INJURIES REPORTED AS RESULTED OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON 20NOV2025*** IT WAS FURTHER REPORTED THAT THE MISPLACEMENT WAS NOTED PRIOR TO THE STEREOTACTIC BODY RADIATION THERAPY (SBRT), NO ACTIONS WERE TAKEN AT THIS TIME. THE RADIATION TREATMENT WAS DELIVERED IN FIVE FRACTIONS DURING MAY.
IT WAS REPORTED THAT AFTER THE SPACEOAR PLACEMENT PROCEDURE, THE ACCOUNT REPORTED THAT THERE WAS A POTENTIAL INFILTRATION OF THE HYDROGEL IN THE RECTAL WALL. THERE WERE NO SERIOUS INJURIES REPORTED AS RESULTED OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248396 | SPACEOAR VUE SYSTEM | ABSORBABLE PERIRECTAL SPACER | OVB | BOSTON SCIENTIFIC CORPORATION | SV-1010 | 30447481 | 00850009803009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |