SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2024-04878
- Event Type
- Malfunction
- Date Received
- October 4, 2024
- Date of Event
- September 9, 2024
- Report Date
- December 8, 2024
- 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 A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK E1 (INITIAL REPORTER FACILITY NAME): THE SECOND AFFILIATED HOSPITAL OF (B)(6) UNIVERSITY. BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.
BLOCK E1 (INITIAL REPORTER FACILITY NAME): THE SECOND AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY 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 HAD SIX BANDS ATTACHED, WHICH MATCHES TO THE FINDINGS PER MEDIA ANALYSIS ON THE PROVIDED PHOTO. THE LIGATOR HOUSING TEETH WERE FOUND BENT AND BROKEN. THE HANDLE HAD MARKS OF THE TRIP WIRE INDICATING THAT IT WAS SECURED, AND THE SUTURE WAS FOUND BROKEN. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF THE BANDS UNABLE TO DEPLOY WAS CONFIRMED. UPON ANALYSIS, THE RETURNED LIGATOR HOUSING RETURNED HAD SIX BANDS ATTACHED TO IT AND THE LIGATOR HOUSING TEETH WERE FOUND BENT AND BROKEN, AND THE SUTURE WAS BROKEN. ALTHOUGH THE RETURNED DEVICE HAS BROKEN SUTURE; HOWEVER, THIS CONDITION IS NOT CONSIDERED A FAILURE MODE BECAUSE THIS CONDITION MOST LIKELY OCCURRED WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE SCOPE. IT IS POSSIBLE THAT THIS PROBLEM WHEN TRYING TO DEPLOY THE BANDS, MIGHT HAVE TO DO WITH THE TECHNIQUE USED BY THE PHYSICIAN OR THE WAY THE DEVICE IS BEING HANDLED, PERHAPS THE WAY THE DEVICE WAS PLACED OR THE TORTUOSITY DURING THE PROCEDURE WAS AFFECTING THE FUNCTIONALITY OF THE HANDLE, AND THIS MADE THE BANDS FEEL DIFFICULT TO BE DEPLOYED. THE MARKS ON THE LIGATOR HOUSING TEETH IMPLIES THAT THE DEVICE MIGHT HAVE BEEN USED WITH TOO MUCH FORCE IN ORDER FOR THE TEETH GET DAMAGED OR PERHAPS THIS COULD BE ATTRIBUTED TO THE WAY THE PHYSICIAN WAS ENTERING THE DEVICE THROUGH THE PATIENT, COULD HAVE ALSO AFFECTED THE FUNCTIONALITY OF THE HANDLE WHEN DEPLOYING THE BANDS. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.
BLOCK H2 (ADDITIONAL INFORMATION). BLOCK A1 (PATIENT IDENTIFIER), BLOCK A2 (AGE AT TIME OF EVENT), BLOCK B5, BLOCK E1 (INITIAL REPORTER ADDRESS 1, INITIAL REPORTER ADDRESS 2, INITIAL REPORTER CITY, INITIAL REPORTER ZIP/POST CODE), BLOCK H6 (DEVICE CODES), AND BLOCK H11 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 10, 2024. BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A LIGATION OF STOMACH FUNDUS AND ESOPHAGUS PROCEDURE TO TREAT VARICEAL HEMORRHAGE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED. 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. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: IT WAS REPORTED THAT THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE STOMACH FUNDUS; HOWEVER, PER THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR INSTRUCTIONS FOR USE (IFU), THE DEVICE IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION AND THE REPORTED ANATOMY LOCATION IS NOT DESCRIBED IN THE INDICATIONS FOR USE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A LIGATION OF STOMACH FUNDUS AND ESOPHAGUS PROCEDURE TO TREAT VARICEAL HEMORRHAGE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED. 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. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 10, 2024: THE SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING A VARICEAL LIGATION PROCEDURE TO TREAT VARICEAL BLEEDING. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE BANDS WERE MOVED WITHIN THE LIGATOR CAP.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A LIGATION OF STOMACH FUNDUS AND ESOPHAGUS PROCEDURE TO TREAT VARICEAL HEMORRHAGE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BANDS COULD NOT BE DEPLOYED. 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. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 10, 2024: THE SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING A VARICEAL LIGATION PROCEDURE TO TREAT VARICEAL BLEEDING. IT WAS NOTED THAT NO DIFFICULTY WAS EXPERIENCED UPON SETTING UP THE DEVICE. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWED THE BANDS WERE MOVED WITHIN THE LIGATOR CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725965 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542251 | 0033878538 | 08714729201960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |