SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2025-01851
- Event Type
- Malfunction
- Date Received
- April 29, 2025
- Date of Event
- April 8, 2025
- Report Date
- July 2, 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 H6: IMDRF DEVICE CODE A0203 CAPTURES THE REPORTABLE EVENT OF BANDS DAMAGE.
BLOCK H6: IMDRF DEVICE CODE A0203 CAPTURES THE REPORTABLE EVENT OF BANDS DAMAGE. LOCK H11: INVESTIGATION RESULTS THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS ANALYZED, AND DURING MEDIA INSPECTION, IT WAS SEEN THAT THE PHOTO ATTACHED SHOWED A HANDLE WITH NO DAMAGES NOTICED. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE HANDLE WAS RETURNED WITH NO DAMAGES. THE TRIP WIRE WAS SECURED INTO THE HANDLE SLOT. A FUNCTIONAL INSPECTION WAS PERFORMED, AND IT WAS SEEN THAT THE HANDLE IS ABLE TO ROTATE WITHOUT ANY ISSUES. THE LIGATOR HOUSING WAS NOT RETURNED. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS DAMAGED WAS NOT CONFIRMED. THE RETURNED DEVICE REVIEW SHOWED NO EVIDENCE OF EITHER THE ALLEGED OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS NO PROBLEM DETECTED.
BLOCK H6: IMDRF DEVICE CODE A0203 CAPTURES THE REPORTABLE EVENT OF BANDS DAMAGE. BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM) AND BLOCK E1 (INITIAL REPORTER ADDRESS 2 AND INITIAL REPORTER ZIP/POST CODE) HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MAY 7, 2025.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE FUNDUS OF THE STOMACH DURING A GASTRIC VARICOSE LIGATION PROCEDURE PERFORMED ON (B)(6) 2025, FOR THE TREATMENT OF VARICOSE VEINS. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED WHEN UNPACKAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. 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. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED IN THE FUNDUS OF THE STOMACH; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE FUNDUS OF THE STOMACH DURING A GASTRIC VARICOSE LIGATION PROCEDURE PERFORMED ON (B)(6) 2025, FOR THE TREATMENT OF VARICOSE VEINS. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED WHEN UNPACKAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. 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. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED IN THE FUNDUS OF THE STOMACH; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION. ADDITIONAL INFORMATION RECEIVED ON MAY 7, 2025. IT WAS CLARIFIED THAT THE ANATOMY LOCATION WAS IN THE ESOPHAGUS. THE PROCEDURE PERFORMED WAS FOR THE TREATMENT OF ESOPHAGEAL VARICES.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE FUNDUS OF THE STOMACH DURING A GASTRIC VARICOSE LIGATION PROCEDURE PERFORMED ON (B)(6) 2025, FOR THE TREATMENT OF VARICOSE VEINS. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED WHEN UNPACKAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. 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. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED IN THE FUNDUS OF THE STOMACH; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION. ADDITIONAL INFORMATION RECEIVED ON MAY 7, 2025: IT WAS CLARIFIED THAT THE ANATOMY LOCATION WAS IN THE ESOPHAGUS. THE PROCEDURE PERFORMED WAS FOR THE TREATMENT OF ESOPHAGEAL VARICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1428929 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542251 | 0034003501 | 08714729201960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male |