SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2025-02271
- Event Type
- Malfunction
- Date Received
- May 19, 2025
- Date of Event
- April 14, 2025
- Report Date
- July 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- UDI-DI
- 08714729201953
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY D2B: ADDITIONAL PRODUCT CODE- FHN. E3: NON-HEALTHCARE PROFESSIONAL IS QUALITY ASSURANCE COORDINATOR FOR THE DISTRIBUTOR
BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY. D2B: ADDITIONAL PRODUCT CODE FHN. ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM. CORRECTION: H6: PATIENT CODE.
BLOCK H6: IMDRF CODE A050501 CAPTURES THE REPORTABLE EVENT OF BAND FAILURE TO DEPLOY. D2B: ADDITIONAL PRODUCT CODE FHN. ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM. CORRECTION: E1: INITIAL REPORTER TITLE, FIRST NAME, LAST NAME, FACILITY NAME, ADDRESS, CITY AND PHONE. E2: HEALTH PROFESSIONAL. E3: OCCUPATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN AN UNKNOWN ANATOMY LOCATION DURING A BAND LIGATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST TWO VARICES WERE CORRECTLY LIGATED. WHEN USING THE THIRD BAND, IT BECAME ENTANGLED WITH ANOTHER BAND AND COULD NOT BE DEPLOYED, NOR COULD THE REMAINING FOUR BANDS, MAKING IT DIFFICULT TO DISPOSE OF THE BANDS AFTER USE. PROCEDURE COMPLETION METHOD IS CURRENTLY UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS HAVE BEEN MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS BEEN UNABLE TO BE OBTAINED TO DATE.
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 PROCEDURE, THE FIRST TWO VARICES WERE CORRECTLY LIGATED. WHEN USING THE THIRD BAND, IT BECAME ENTANGLED WITH ANOTHER BAND AND COULD NOT BE DEPLOYED, NOR COULD THE REMAINING FOUR BANDS, MAKING IT DIFFICULT TO DISPOSE OF THE BANDS AFTER USE. THE PATIENT BEGAN TO HAVE BLEEDING BECAUSE THE BAND GOT STUCK INSIDE THE DEVICE. THE STUCK BAND WAS REMOVED BY IRRIGATING WITH SOLUTION. PROCEDURE WAS COMPLETED WITH THE SAME SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS HAVE BEEN MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS BEEN UNABLE TO BE OBTAINED TO DATE.
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 PROCEDURE, THE FIRST TWO VARICES WERE CORRECTLY LIGATED. WHEN USING THE THIRD BAND, IT BECAME ENTANGLED WITH ANOTHER BAND AND COULD NOT BE DEPLOYED, NOR COULD THE REMAINING FOUR BANDS, MAKING IT DIFFICULT TO DISPOSE OF THE BANDS AFTER USE. PROCEDURE WAS COMPLETED WITH THE SAME SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2050685 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, HEMORRHOIDAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542250 | 0035148625 | 08714729201953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |