CONTOUR ERCP CANNULA

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE (B)(6) 2009, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2009 AND DECEMBER 2016. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL, REPORTED HERE AS THE NAME EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE JOURNAL ARTICLE: LEE Y, ET AL. "USEFULNESS AND COMPLICATIONS OF NEEDLE KNIFE FISTULOTOMY AS A RESCUE PROCEDURE IN PATIENTS WITH PANCREATICOBILIARY DISEASE" KOREAN J GASTROENTEROL 2020; HTTPS://DOI.ORG/10.4166/KJG.2020.75.6.341. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION (HYPERAMYLASEMIA).

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05813 AND 3005099803-2024-05815 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ULTRATOME XL SPHINCTEROTOMES, FLUORO TIP ERCP CATHETERS, AND NEEDLE KNIFE PAPILLOTOMES, THROUGH THE ARTICLE, USEFULNESS AND COMPLICATIONS OF NEEDLE KNIFE FISTULOTOMY AS A RESCUE PROCEDURE IN PATIENTS WITH PANCREATICOBILIARY DISEASE, BY YONG JAE LEE, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2009 AND DECEMBER 2016, PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, AND THE FOLLOWING OCCURRED: MILD AND MODERATE PANCREATITIS, BLEEDING AND HYPERAMYLASEMIA. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.