BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR PRO XL

    MDR report key: 17218609 · Received June 28, 2023

    Report

    Report Number
    3005099803-2023-03489
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729790648
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE. IMDRF CODE A0406 CAPTURES THE REPORTABLE EVENT OF BALLOON DEFORMATION.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GAS COULD NOT BE LET OFF AFTER INFLATING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. CORRECTION: THE CUSTOMER ALSO REPORTED THAT THE BALLOON WAS SEEN BULGING AFTER INFLATION. A PHOTO SUBMITTED BY THE CUSTOMER SHOWS AN IRREGULAR SHAPED INFLATED BALLOON OUTSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GAS COULD NOT BE LET OFF AFTER INFLATING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120706 EXTRACTOR PRO XL CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00547120 0029326859 08714729790648

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male