SPACEOAR VUE SYSTEM
Report
- Report Number
- 2124215-2024-58928
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- April 23, 2024
- Report Date
- October 25, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OVB
- UDI-DI
- 00864661000140
- PMA / PMN Number
- K182971
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE E2330 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PAIN.
BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE E2330 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PAIN. BLOCK H11: BLOCK H6 (PATIENT CODES): WERE CORRECTED BASED ON ADDITIONAL INFORMATION RECEIVED ON 10/01/2024.
IT WAS REPORTED THAT AFTER SPACEOAR VUE AND FIDUCIAL MARKERS PLACEMENT. THE PATIENT EXPERIENCED PERINEAL PAIN. AFTER UNDERGOING RADIATION, HE CONSULTED ANOTHER PHYSICIAN DUE TO EXPERIENCING IRRITATIVE PAIN WITHOUT GROSS HEMATURIA. THE PATIENT ALSO EXPERIENCED TENESMUS. THIS LED TO MULTIPLE EMERGENCY ROOM VISITS AND, ULTIMATELY, A HOSPITALIZATION LAST WEEK FOR SEVERE, UNCONTROLLED PERINEAL PAIN. THE MAGNETIC RESONANCE IMAGING DID NOT SHOW ANY PROSTATIC ABSCESS, AND THE SPACEOAR WAS STILL IN PLACE. HOWEVER, THERE WAS CONCERN ABOUT THE HYDROGEL BEING VERY CLOSE TO THE RECTAL LINING. A SIGMOIDOSCOPY REVEALED A SIGNIFICANT ULCER, AND A FOLEY CATHETER WAS INSERTED TO ALLEVIATE URINARY SYMPTOMS. THE HYDROGEL CREATED A 1.5 CM SEPARATION BETWEEN THE RECTUM AND THE PROSTATE FROM THE BASE TO THE APEX. FURTHER IMAGE REVIEW INDICATED THAT THE GEL WAS APPROPRIATELY POSITIONED AT THE BASE, BUT AS IT MOVED TOWARDS THE MIDGLAND AND ESPECIALLY THE APEX, THERE APPEARED TO BE RECTAL WALL INFILTRATION. THE ENDOSCOPY IMAGES CONFIRMED AN ULCER ON THE ANTERIOR RECTAL WALL. THE PATIENT CONTINUED TO EXPERIENCE PAIN BUT SHOWED IMPROVEMENT WITH STEROID TREATMENT. THE PATIENT ALSO COMPLETED THE RADIATION TREATMENT.
IT WAS REPORTED THAT AFTER SPACEOAR VUE AND FIDUCIAL MARKERS PLACEMENT. THE PATIENT EXPERIENCED PERINEAL PAIN. AFTER UNDERGOING RADIATION, HE CONSULTED ANOTHER PHYSICIAN DUE TO EXPERIENCING IRRITATIVE PAIN WITHOUT GROSS HEMATURIA. THE PATIENT ALSO EXPERIENCED TENESMUS. THIS LED TO MULTIPLE EMERGENCY ROOM VISITS AND, ULTIMATELY, A HOSPITALIZATION LAST WEEK FOR SEVERE, UNCONTROLLED PERINEAL PAIN. THE MAGNETIC RESONANCE IMAGING DID NOT SHOW ANY PROSTATIC ABSCESS, AND THE SPACEOAR WAS STILL IN PLACE. HOWEVER, THERE WAS CONCERN ABOUT THE HYDROGEL BEING VERY CLOSE TO THE RECTAL LINING. A SIGMOIDOSCOPY REVEALED A SIGNIFICANT ULCER, AND A FOLEY CATHETER WAS INSERTED TO ALLEVIATE URINARY SYMPTOMS. THE HYDROGEL CREATED A 1.5 CM SEPARATION BETWEEN THE RECTUM AND THE PROSTATE FROM THE BASE TO THE APEX. FURTHER IMAGE REVIEW INDICATED THAT THE GEL WAS APPROPRIATELY POSITIONED AT THE BASE, BUT AS IT MOVED TOWARDS THE MIDGLAND AND ESPECIALLY THE APEX, THERE APPEARED TO BE RECTAL WALL INFILTRATION. THE ENDOSCOPY IMAGES CONFIRMED AN ULCER ON THE ANTERIOR RECTAL WALL. THE PATIENT CONTINUED TO EXPERIENCE PAIN BUT SHOWED IMPROVEMENT WITH STEROID TREATMENT. THE PATIENT ALSO COMPLETED THE RADIATION TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1483362 | SPACEOAR VUE SYSTEM | ABSORBABLE PERIRECTAL SPACER | OVB | BOSTON SCIENTIFIC CORPORATION | SV-2101 | 00864661000140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention| H |