SPEEDBAND SUPERVIEW SUPER 7
Report
- Report Number
- 3005099803-2022-04181
- Event Type
- Malfunction
- Date Received
- August 3, 2022
- Date of Event
- July 12, 2022
- Report Date
- September 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MND
- UDI-DI
- 08714729201953
- PMA / PMN Number
- 510K EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE DEVICE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. BLOCK E1 (INITIAL REPORTER PHONE): +011(886)2282644002323BLOCK H6:MEDICAL DEVICE CODE A050501 CAPTURES THE REPORTABLE EVENT OF BANDS UNABLE TO DEPLOY. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (LIGATOR HEAD ONLY) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE RETURNED LIGATOR HEAD HAD ALL THE BANDS ATTACHED TO IT, AND SOME BANDS WERE MOVED OUT OF THEIR POSITION, AND ONE BAND OVERLAPPED. THE SUTURE HOLE WAS TORN, AND SOME LIGATOR HEAD TEETH WERE DAMAGED/BENT, WHICH ARE CONSISTENT WITH THE FINDINGS WHEN THE DEVICE WAS OBSERVED UNDER MAGNIFICATION. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF BANDS UNABLE TO DEPLOY WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE LIGATOR HEAD TEETH WERE BENT/DAMAGED AND THE BANDS ON THE LIGATOR HEAD WERE MOVED, AND ONE BAND OVERLAPPED. THESE SUGGEST THAT THE DEVICE COULD NOT DEPLOY. THESE CONDITIONS COULD HAVE BEEN GENERATED DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE WHICH COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO MOVE THE SUTURE KNOTS FROM THEIR POSITION IN THE LIGATION UNIT. THIS WOULD RESULT IN MORE TENSION APPLIED TO THE COMPONENT LEADING TO BEND THE TEETH, TEAR THE SUTURE HOLE AND CONSEQUENTLY, CAUSING THE INABILITY OF THE DEVICE TO DEPLOY THE BANDS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE HANDLE WAS ROTATED, THE BANDS TWISTED AND DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT THERE WAS NO ANY DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE HANDLE WAS ROTATED, THE BANDS TWISTED AND DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT THERE WAS NO ANY DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1871534 | SPEEDBAND SUPERVIEW SUPER 7 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC CORPORATION | M00542250 | 08714729201953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |