BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 10572153 · Received September 23, 2020

    Report

    Report Number
    3001845648-2020-00648
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    November 20, 2002
    Report Date
    June 10, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL INPUT RECEIEVD CONFIRMS THAT THE DEVICE WAS NOT THE CAUSE OF THE PANCREATITIS. (AS PER ADVISOR ON 10-JUNE-21: 'THE 2 CASE OF PANCREATITIS WAS NOT RELATED TO COOK STENT. ON THE CONTRARY, PANCREATIC DUCT STENT INSERTION AFTER ERCP REDUCES THE FREQUENCY OF POST-ERCP PANCREATITIS.') RE ASSESSMENT REQUIRED. CANCELLATION REPORT BEING SUBMITTED.

    Description of Event or Problem · 0

    CLINICAL INPUT RECEIVED CONFIRMS THAT THE DEVICE WAS NOT THE CAUSE OF THE PANCREATITIS. (AS PER ADVISOR ON 10-JUNE-2021: 'THE 2 CASE OF PANCREATITIS WAS NOT RELATED TO COOK STENT. ON THE CONTRARY, PANCREATIC DUCT STENT INSERTION AFTER ERCP REDUCES THE FREQUENCY OF POST-ERCP PANCREATITIS.') RE ASSESSMENT REQUIRED. CANCELLATION REPORT BEING SUBMITTED. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ BASED ON MEDICAL ADVISOR INPUT STATING THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO PANCREATITIS AND NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    FAZEL ET AL 2003 ¿DOES A PANCREATIC DUCT STENT PREVENT POST-ERCP PANCREATITIS? A PROSPECTIVE RANDOMIZED STUDY". THE STUDY WAS CONDUCTED AT A TERTIARY PANCREATICOBILIARY REFERRAL CENTER OVER A 6-YEAR PERIOD. THE STUDY GROUP CONSISTED OF PATIENTS OVER 18 YEARS OF AGE AT HIGH RISK FOR POST-ERCP PANCREATITIS BECAUSE OF A DIFFICULT CANNULATION, SO MANOMETRY, OR THE PERFORMANCE OF ENDOSCOPIC SPHINCTEROTOMY. PATIENTS WERE RANDOMIZED TO RECEIVE A PD STENT OR NO STENT UPON COMPLETION OF THE ERCP. THE ENDOPROSTHESIS USED WAS EITHER A 5 F NASOPANCREATIC CATHETER (NPC) OR 5 F, 2-CM LONG PANCREATIC STENT. THE NPC (WILSON COOK MEDICAL INC., WINSTON-SALEM, N.C.) WAS PLACED ENDOSCOPICALLY OVER A GUIDEWIRE UNDER FLUOROSCOPIC GUIDANCE. IT WAS THEN REROUTED BY MEANS OF THE NARES IN STANDARD FASHION AND CONNECTED TO GRAVITY DRAINAGE. IN PATIENTS IN WHOM PD DRAINAGE WAS ACHIEVED BY PD STENT INSERTION, THE STENT WAS PLACED ENDOSCOPICALLY OVER A GUIDEWIRE UNDER FLUOROSCOPIC GUIDANCE. A 5 F, 2-CM LONG, 2 BARBED, GEENEN STENT (WILSON COOK) WAS PLACED WITH THE DISTAL END PROTRUDING 0.5 TO 1 CM INTO THE DUODENUM. THE STENT WAS PLACED AFTER DEEP CANNULATION WAS OBTAINED AND ALL ENDOSCOPIC INTERVENTIONS HAD BEEN COMPLETED. IF THE STENT HAD NOT PASSED SPONTANEOUSLY A SECOND ENDOSCOPY WAS PERFORMED TO REMOVE THE STENT. OF THE 86 PATIENTS ENROLLED, 76 WERE AT HIGH RISK FOR POST-ERCP PANCREATITIS AND WERE RANDOMLY ALLOCATED TO THE PD STENT (NPC OR PD STENT) GROUP AFTER ERCP OR THE NO STENT GROUP (CONTROL GROUP). 36 PATIENTS IN THE STENT GROUP AND 38 PATIENTS IN THE CONTROL GROUP PATIENTS UNDERGOING PD DRAINAGE WITH A STENT OR NPC HAD A LOWER FREQUENCY OF POST-ERCP PANCREATITIS AS COMPARED WITH THOSE IN THE CONTROL GROUP (5% VS. 27%; P < 0.05) (TABLES 2 AND 3). IN ALL CASES, PANCREATITIS IN THE PD STENT GROUP WAS MILD. THE MEAN DURATION OF HOSPITALIZATION FOR POST-ERCP PANCREATITIS WAS SHORTER IN THE PD STENT GROUP AS COMPARED WITH THE CONTROL GROUP (2.5 DAYS VS. 5.5 DAYS). PANCREATITIS WAS CONSIDERED MILD IF HOSPITALIZATION WAS PROLONGED TO 2 TO 3 DAYS AFTER THE PROCEDURE POST -ERCP PANCREATITIS WAS ALSO PRESENT IN 2 PATIENTS IN THE GEENEN & NPDS-5 GROUP, HOWEVER IT IS UNKNOWN WHICH DEVICE WAS PLACED. THIS FILE WAS CREATED TO CAPTURE THE POSSIBLE POST -ERCP PANCREATITIS WITH NPDS-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037891 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization