BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 17869393 · Received October 4, 2023

    Report

    Report Number
    3001845648-2023-00755
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 1, 2023
    Report Date
    April 4, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002214665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K171623.INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171623. CANCELLATION REPORT IS BEING SUBMITTED DUE TO CLINICAL INPUT RECEIVED ON 04-APR-2024. 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)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    NPDS-5 WAS USED FOR SPACE (SERIAL PANCREATIC JUICE ASPIRATION CYTOLOGICAL EXAMINATION) IN A PATIENT WITH SUSPECTED IPMN (INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM).THE PANCREATIC DUCT WAS TORTUOUS AND STENOTIC, AND THE INSERTION OF NPDS-5 WAS DIFFICULT. IT COULD NOT BE SUCCESSFULLY IMPLANTED, AND WHEN IT WAS TAKEN OUT OF THE PATIENT, THE TIP OF THE TUBE WAS SEVERED.THE PROCEDURE WAS FINISHED AFTER COLLECTING THE SEVERED PART OF THE TUBE.NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.<PHYSICIAN'S COMMENT>I DON'T THINK THE CAUSE IS A PRODUCT DEFECT, BUT RATHER THE ANATOMICAL SITUATION OF THE PATIENT.<SALES REP'S COMMENT>THIS DOCTOR USES THIS PRODUCT ON A REGULAR BASIS SO I DON'T SEE A PROBLEM WITH HER USAGE.1 WAS THE DEVICE FLUSHED BEFORE USE? YES.2 WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, CONTRAST, ETC.)? WATER.3 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? PLEASE SEE THE DESCRIPTION OF EVENT.4 DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? OLYMPUS/VISIGLIDE2 0.025 ANGLED5 WHAT WAS THE TARGET LOCATION IN THE BODY FOR USE OF THIS DEVICE? PANCREATIC DUCT. 6 WAS THE PATIENT¿S ANATOMY TORTUOUS? YES, STORONG TORTUOSITY.7 WHAT WAS THE PATIENT¿S PRE-EXISTING CONDITION(S)? UNKNOWN.8 WAS THE DEVICE STRAIGHTENED WITH THE PIGTAIL STRAIGHTENER (IF APPLICABLE)? 9 WAS THE ISSUE OBSERVED DURING DEVICE PREP, DURING ADVANCEMENT OR ON REMOVAL OF THE DEVICE FROM THE PATIENT? PLEASE SEE THE DESCRIPTION OF EVENT.10 WERE ANY ADDITIONAL DEFECTS OR ISSUES, OTHER THAN THE COMPLAINT ISSUE, OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK, BEND, BREAK ETC.)? NO.11 IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT WAS OBSERVED (E.G. KINK, BEND, BREAK) 12 IF ADDITIONAL DEFECTS WERE IDENTIFIED, PLEASE STATE WHERE THE DEFECT WAS OBSERVED ON THE DEVICE. 13 WAS THE PACKAGING DAMAGED PRIOR TO DEVICE USE? NO.14 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES 15 WHAT INTERVENTION (IF ANY) WAS REQUIRED? COLLECTION OF THE SEVERED TUBE PART.16 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? (SAME PROCEDURE). IN RELATION TO COMPLAINTS OCCURRING DURING PLACEMENT AND/OR USE ALSO ASK: 1 WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? OLYMPUS/JF-260V.2 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE INTO POSITION? NO.3 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DRAINAGE CATHETER INTO POSITION? UNKNOWN. THE DOCTOR SAID SHE HAD TRIED EVERYTHING.4 WAS A DRAINAGE CATHETER LOOP PLACED IN THE DESCENDING PORTION OF THE DUODENUM? NO. 5 AFTER PLACEMENT, WAS DRAINAGE CATHETER POSITION VERIFIED? IF YES, PLEASE DESCRIBE HOW. NO. 6 PLEASE ESTIMATE AMOUNT OF TIME THE DRAINAGE CATHETER WAS IN PLACE PRIOR TO THIS OCCURRENCE. 7 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? YES.

    Description of Event or Problem · 0

    CANCELLATION REPORT IS BEING SUBMITTED DUE TO CLINICAL INPUT RECEIVED ON 04-APR-2024. 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)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116976 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C2062489 10827002214665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention