BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 15396347 · Received September 9, 2022

    Report

    Report Number
    3005099803-2022-05097
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 10, 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

    Additional Manufacturer Narrative · 0

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0406 CAPTURES THE REPORTABLE EVENT OF SUTURE HAVE MULTIPLE KNOTS. BLOCK H10: THE RETURNED SPEEDBAND SUPERVIEW SUPER 7 (LIGATOR HOUSING ONLY) WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE LIGATOR HOUSING WAS IN GOOD CONDITION AND IT HAD THE SEVEN BANDS ATTACHED WITHOUT THE SHRINK WRAP. THE SUTURE THREAD PULLING LOOP HAD AN EXTRA KNOT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF SUTURE HAD MULTIPLE KNOTS IN THE LIGATOR WAS CONFIRMED. UPON ANALYSIS, IT WAS OBSERVED THAT THE RETURNED LIGATOR HOUSING HAD AN ADDITIONAL KNOT IN THE PULLING LOOP WITH THE SUTURE THREAD AND BANDS WERE ALL WELL-PLACED. THERE WAS NO OBJECTIVE EVIDENCE TO UNDERSTAND HOW THE EXTRA KNOT WAS MADE, SO, FURTHER INVESTIGATION WAS REQUIRED TO DELVE INTO THE POSSIBLE CIRCUMSTANCES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT. THE INVESTIGATION FINDINGS DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS INTENDED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE SUTURE HAD TWO KNOTS ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS INTENDED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE SUTURE HAD TWO KNOTS ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360207 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542250 08714729201953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown