SPEEDBAND SUPERVIEW SUPER 7¿
Report
- Report Number
- 3005099803-2012-05447
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- MND
- PMA / PMN Number
- K020824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
Narratives
THE EXACT PATIENT AGE IS UNKNOWN HOWEVER: IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
A VISUAL EXAMINATION FOUND THAT THE HANDLE ASSEMBLY, TRIPWIRE, SUTURE, AND LIGATOR HEAD WERE RETURNED FOR EVALUATION. THERE WAS RESIDUE PRESENT ON THE DEVICE WHICH IS INDICATIVE OF USE. THE EVALUATION REVEALED THAT THE LIGATOR HEAD RETURNED WITH SIX BANDS PRESENT; FIVE BLUE AND ONE WHITE. ALL BANDS WERE ROLLED OUT OF POSITION. IN ADDITION, THE LIGATOR TEETH WERE VISIBLY DAMAGED. THE SUTURE, WHICH RETURNED BROKEN, WAS ATTACHED PROXIMALLY TO THE TRIPWIRE LOOP AND DISTALLY TO THE LIGATOR HEAD. FURTHER ANALYSIS OF THE HANDLE ASSEMBLY REVEALED THAT THE TRIPWIRE WAS CINCHED (SECURED) IN THE HANDLE ASSEMBLY SLOT. FURTHERMORE, THE PROXIMAL SECTION OF THE TRIPWIRE WAS FOUND TO BE CURLED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE RETURNED DEVICE VISUALLY REFLECTS THE REPORTED ISSUE. THE EVALUATION FOUND THAT THE LIGATOR HEAD RETURNED WITH DAMAGED TEETH, AND SIX BANDS PRESENT, BUT ROLLED OUT OF POSITION. ADDITIONALLY, THE SUTURE WAS FOUND TO BE BROKEN. THIS DAMAGE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE AND ADVERSELY IMPACTED BAND DEPLOYMENT ACTIVITIES. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL VARICE LIGATION (EVL) PROCEDURE, WITHIN THE MIDDLE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BAND WAS DEPLOYED WITHOUT ISSUE HOWEVER; WHEN AN ATTEMPT TO DEPLOY THE SECOND BAND WAS MADE, THE BAND FAILED TO DEPLOY OFF THE LIGATOR HEAD. REPORTEDLY, IT WAS NOTICED THAT THE THIRD BLUE BAND WAS TANGLED WITH THE WHITE (ALERT) BAND. THE CASE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL VARICE LIGATION (EVL) PROCEDURE, WITHIN THE MIDDLE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BAND WAS DEPLOYED WITHOUT ISSUE HOWEVER; WHEN AN ATTEMPT TO DEPLOY THE SECOND BAND WAS MADE, THE BAND FAILED TO DEPLOY OFF THE LIGATOR HEAD. REPORTEDLY, IT WAS NOTICED THAT THE THIRD BLUE BAND WAS TANGLED WITH THE WHITE (ALERT) BAND. THE CASE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDBAND SUPERVIEW SUPER 7¿ | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC - SPENCER | M00542250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |