SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2025-03999
- Event Type
- Malfunction
- Date Received
- August 18, 2025
- Date of Event
- July 25, 2025
- Report Date
- January 2, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- UDI-DI
- 08714729201960
- PMA / PMN Number
- 510K EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
BLOCK E1: THIS EVENT WAS REPORTED BY A BSC SALES REP. THE REPORTED HEALTHCARE FACILITY IS: (B)(6). BLOCK H2: CORRECTION: BLOCK H6 (DEVICE CODES (1)) AND BLOCK H11 (ADDITIONAL MFR NARRATIVE). BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.
BLOCK E1: (B)(6). BLOCK H6: IMDRF DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF BANDS MISFIRE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED FOR VARICES DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BANDS WERE NOT DEPLOYING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED FOR VARICES DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BANDS WERE NOT DEPLOYING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2044471 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542251 | 0035386369 | 08714729201960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |