BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP

    MDR report key: 20044354 · Received August 22, 2024

    Report

    Report Number
    2124215-2024-51833
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 21, 2023
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE PROVIDED EVENT DATE OF JANUARY 21, 2023, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE: ZAIGHAM, H., ENOCHSSON, L., OTTOSON, J., & REGNER, S., "LAPAROSCOPIC TRANSCYSTIC COMMON BILE DUCT EXPLORATION VERSUS TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY DURING CHOLECYSTECTOMY AFTER ROUX-EN-Y GASTRIC BYPASS", SURGERY FOR OBESITY AND RELATED DISEASES VOLUME 19, ISSUE 8, PAGE 882-888, DOI: HTTPS://DOI.ORG/10.1016/J.SOARD.2023.01.023 BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENT OF: E0506 - CAPTURES THE REPORTABLE EVENT OF E1108 - CAPTURES THE REPORTABEL EVENT OF BILE LEAK E1006 - CAPTURES THE REPORTABLE EVENT OF BOWEL PERFORATION E2326 - CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS E172002 - CAPTURES THE REPORTABLE EVENT OF ABSCESS E2328 - CAPTURES THE REPORTABLE EVET OF BILE OBSTRUCTION THE FOLLOWING IMDRF IMPACT CODES CAPTURE THE REPORTABLE EVENT OF: F08 - CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION F1901 - CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERIES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE SURGERY FOR OBESITY RELATED DISEASES THAT A RETROSPECTIVE STUDY WAS CONDUCTED. THE AIM OF THE STUDY WAS TO COMPARE OUTCOMES FOLLOWING LAPAROSCOPIC TRANSCYSTIC COMMON BILE DUCT EXPLORATION (LTCBDE) AND LAPAROSCOPY-ASSISTED TRANSGASTRIC ERC FOR CBDS DURING CHOLECYSTECTOMY IN RYGB OPERATED PATIENTS. DATA FROM THE SWEDING REGISTRY FOR GALLSTONE SURGERY AND ENDOSCOPIC RETROGRADE CHOLANGIOGRAM (ERC), AND THE SCANDINAVIAN OBESITY SURGERY REGISTRY WERE CROSS-MATCHED FOR CHOLECYSTECTOMIES WITH INTRAOPERATIVELY ENCOUNTERED COMMON BILE DUCT (CBD) STONES IN PATIENTS WITH PREVIOUS ROUX-EN-Y GASTRIC BYPASS (RYGB) SURGERY BETWEEN 2011 AND 2020, FINDING 550 PATIENTS FOR ANALYSIS. GEMINI AND ZERO TIP BASKETS WERE USED IN THE LAPAROSCOPIC TRANSCYSTIC CBD EXPLORATION TO CAPTURE LARGER STONES. SOME INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS WHERE PRESENT IN THE DATA; SUCH AS ABSCESS (7 CASES), BLEEDING (7 CASES), BILE LEAK (6 CASES), BOWEL PERFORATION (2 CASES) AND CHOLANGITIS (2 CASES); THERE WAS A CASE OF BILE OBSTRUCTION TOO. ADDITIONALLY, THERE WERE INCIDENCES OF ADDITIONAL SURGERIES IN 9 CASES AND A PROLONGED HOSPITALIZATION IN 4 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256747 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| H