BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 9443751 · Received December 10, 2019

    Report

    Report Number
    3001845648-2019-00703
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Report Date
    January 31, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K092359. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY REPORTED BASED ON USER ERROR. ADDITIONAL CLARIFICATION FROM PRODUCT MANAGER AND FROM CLINICAL PERSONNEL CONFIRMED THE USE OF THIS DEVICE WAS NOT OFF LABEL AND IT WAS USED AS PER THE DEVICE INDICATION. THIS REPORT IS BEING SUBMITTED AS A CANCELLATON REPORT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PAPER TITLE: DRAINAGE OF THE RIGHT LIVER UNDER EUS GUIDANCE: A BRIDGE TECHNIQUE ALLOWING DRAINAGE OF THE RIGHT LIVER THROUGH THE LEFT LIVER INTO THE STOMACH OR JEJUNUM. COUNTRY OF ORIGIN: FRANCE. PATIENT CONDITIONS: PATIENTS WITH INACCESSIBLE PAPILLA DUE TO ALTERED ANATOMY OR DUODENAL INVASION AND DRAINAGE UNDER EUS GUIDANCE AND BRIDGE TECHNIQUE WITHOUT PREVIOUS BILIARY DRAINAGE WERE INCLUDED IN THE STUDY. BRIEF DESCRIPTION: BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE. (RELATED TO (B)(4)). EVENT DESCRIPTION: TWELVE PATIENTS WERE INCLUDED IN THE STUDY. INCLUSION CRITERIA WERE MALIGNANT HILAR STENOSIS OF THE BILE DUCT, INACCESSIBLE PAPILLA DUE TO DUODENAL STENOSIS OR ALTERED ANATOMY, AND AN ATTEMPT OF THE BRIDGE TECHNIQUE. THE PROCEDURE WAS PERFORMED WITH PATIENTS INTUBATED AND SEDATED AND IN THE SUPINE POSITION. THE LIVER SEGMENT II OR III WAS PUNCTURED WITH A 19 G ACCESS NEEDLE ((ECHOTIP ULTRA 19- A, COOK MEDICAL, USA) OR A STANDARD 19 G NEEDLE (ECHOTIP ULTRA 19, COOK MEDICAL) WITH A THERAPEUTIC ECHOENDOSCOPE (EG38UTK [PENTAX, (B)(6) , JAPAN]). BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE.

    Description of Event or Problem · 0

    PAPER TITLE: DRAINAGE OF THE RIGHT LIVER UNDER EUS GUIDANCE: A BRIDGE TECHNIQUE ALLOWING DRAINAGE OF THE RIGHT LIVER THROUGH THE LEFT LIVER INTO THE STOMACH OR JEJUNUM COUNTRY OF ORIGIN: FRANCE PATIENT CONDITIONS: PATIENTS WITH INACCESSIBLE PAPILLA DUE TO ALTERED ANATOMY OR DUODENAL INVASION AND DRAINAGE UNDER EUS GUIDANCE AND BRIDGE TECHNIQUE WITHOUT PREVIOUS BILIARY DRAINAGE WERE INCLUDED IN THE STUDY. BRIEF DESCRIPTION: BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE. (RELATED TO 285780) EVENT DESCRIPTION: TWELVE PATIENTS WERE INCLUDED IN THE STUDY. INCLUSION CRITERIA WERE MALIGNANT HILAR STENOSIS OF THE BILE DUCT, INACCESSIBLE PAPILLA DUE TO DUODENAL STENOSIS OR ALTERED ANATOMY, AND AN ATTEMPT OF THE BRIDGE TECHNIQUE. THE PROCEDURE WAS PERFORMED WITH PATIENTS INTUBATED AND SEDATED AND IN THE SUPINE POSITION. THE LIVER SEGMENT II OR III WAS PUNCTURED WITH A 19 G ACCESS NEEDLE ((ECHOTIP ULTRA 19- A, COOK MEDICAL, USA) OR A STANDARD 19 G NEEDLE (ECHOTIP ULTRA 19, COOK MEDICAL) WITH A THERAPEUTIC ECHOENDOSCOPE (EG38UTK [PENTAX, TOKYO, JAPAN]). BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE. ADDITIONAL CLARIFICATION FROM PRODUCT MANAGER AND FROM CLINICAL PERSONNEL CONFIRMED THE USE OF THIS DEVICE WAS NOT OFF LABEL AND IT WAS USED AS PER THE DEVICE INDICATION. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #K092359. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    PAPER TITLE: DRAINAGE OF THE RIGHT LIVER UNDER EUS GUIDANCE: A BRIDGE TECHNIQUE ALLOWING DRAINAGE OF THE RIGHT LIVER THROUGH THE LEFT LIVER INTO THE STOMACH OR JEJUNUM. COUNTRY OF ORIGIN: (B)(6). PATIENT CONDITIONS: PATIENTS WITH INACCESSIBLE PAPILLA DUE TO ALTERED ANATOMY OR DUODENAL INVASION AND DRAINAGE UNDER EUS GUIDANCE AND BRIDGE TECHNIQUE WITHOUT PREVIOUS BILIARY DRAINAGE WERE INCLUDED IN THE STUDY. BRIEF DESCRIPTION: BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE. (RELATED TO 285780). EVENT DESCRIPTION: TWELVE PATIENTS WERE INCLUDED IN THE STUDY. INCLUSION CRITERIA WERE MALIGNANT HILAR STENOSIS OF THE BILE DUCT, INACCESSIBLE PAPILLA DUE TO DUODENAL STENOSIS OR ALTERED ANATOMY, AND AN ATTEMPT OF THE BRIDGE TECHNIQUE. THE PROCEDURE WAS PERFORMED WITH PATIENTS INTUBATED AND SEDATED AND IN THE SUPINE POSITION. THE LIVER SEGMENT II OR III WAS PUNCTURED WITH A 19 G ACCESS NEEDLE ((ECHOTIP ULTRA 19- A, COOK MEDICAL, USA) OR A STANDARD 19 G NEEDLE (ECHOTIP ULTRA 19, COOK MEDICAL) WITH A THERAPEUTIC ECHOENDOSCOPE (EG38UTK [PENTAX, (B)(4)]). BOTH ULTRA 19-A AND ULTRA 19 WERE OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242510 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death