SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2024-06447
- Event Type
- Malfunction
- Date Received
- December 24, 2024
- Date of Event
- November 28, 2024
- Report Date
- January 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- UDI-DI
- 08714729201960
- PMA / PMN Number
- 510K EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6) HOSPITAL. BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.
BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. BLOCK H11: CORRECTION: BLOCK H6 (PATIENT CODES).
BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. BLOCK H11: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE LIGATOR HOUSING WAS NOT RETURNED AND ONLY THE HANDLE AND THE IRRIGATION TUBE WERE RETURNED. THE HANDLE HAD MARKS OF THE TRIP WIRE INDICATING THAT IT WAS SECURED. NO PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS UNABLE TO DEPLOY CANNOT BE CONFIRMED. UPON ANALYSIS ON THE RETURNED COMPONENT, THE HANDLE HAD MARKS OF THE TRIP WIRE INDICATING THAT IT WAS SECURED. BASED ON THE LIMITED INFORMATION AVAILABLE AND WITHOUT RETURNED DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS CAUSE NOT ESTABLISHED. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL, THE REPORTED ADVERSE EVENT "HEMORRHAGE, MINOR" IS A KNOWN INHERENT RISK AND IS DOCUMENTED IN THE DEVICE LABELING AND INSTRUCTIONS FOR USE (IFU) AND IT IS NOTED IN THE ADVERSE EVENTS SECTION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE FOR ENDOSCOPIC TREATMENT OF ESOPHAGEAL VARICES PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED ONTO THE VARIX, WHICH RESULTED TO RUPTURE OF THE VENOUS MASS AND BLEEDING. A SECOND SPEEDBAND SUPERVIEW SUPER 7 WAS THEN USED TO ADDRESS THE RUPTURE OF THE VENOUS MASS AND THE BLEEDING, WHICH WAS SUCCESSFULLY RESOLVED. THE PROCEDURE WAS COMPLETED WITH THE SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE FOR ENDOSCOPIC TREATMENT OF ESOPHAGEAL VARICES PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED ONTO THE VARIX, WHICH RESULTED TO RUPTURE OF THE VENOUS MASS AND BLEEDING. A SECOND SPEEDBAND SUPERVIEW SUPER 7 WAS THEN USED TO ADDRESS THE RUPTURE OF THE VENOUS MASS AND THE BLEEDING, WHICH WAS SUCCESSFULLY RESOLVED. THE PROCEDURE WAS COMPLETED WITH THE SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL VARICEAL LIGATION PROCEDURE FOR ENDOSCOPIC TREATMENT OF ESOPHAGEAL VARICES PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED ONTO THE VARIX, WHICH RESULTED TO RUPTURE OF THE VENOUS MASS AND BLEEDING. A SECOND SPEEDBAND SUPERVIEW SUPER 7 WAS THEN USED TO ADDRESS THE RUPTURE OF THE VENOUS MASS AND THE BLEEDING, WHICH WAS SUCCESSFULLY RESOLVED. THE PROCEDURE WAS COMPLETED WITH THE SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS 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 |
|---|---|---|---|---|---|---|---|
| 2509983 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542251 | 0034188386 | 08714729201960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |