FDA Adverse Event
Malfunction
Summary report: N
SPEEDBAND SUPERVIEW SUPER 7
MDR report key: 22297636
·
Received June 20, 2025
Report
- Report Number
- 3005099803-2025-02827
- Event Type
- Malfunction
- Date Received
- June 20, 2025
- Date of Event
- May 26, 2025
- Report Date
- June 20, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- UDI-DI
- 08714729201953
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF CODE A150103 CAPTURES THE REPORTABLE EVENT OF PREMATURE DEPLOYMENT. D2B: ADDITIONAL PRODUCT CODE FHN.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICES LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PREPARATION, THE SPEEDBAND SUPERVIEW SUPER 7 HAD SOME POWDER COME OUT FROM THE PACKAGE. DURING THE PROCEDURE THE SPEEDBAND SUPERVIEW SUPER 7 DEPLOYED 3 BANDS AT ONCE ON THE SAME LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1779612 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, HEMORRHOIDAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542250 | 0035639299 | 08714729201953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |