BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 19881823 · Received August 1, 2024

    Report

    Report Number
    3001845648-2024-00431
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    August 17, 2023
    Report Date
    September 5, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K210476. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "ENDOSCOPIC ULTRASOUND-GUIDED TRANSGASTRIC SHUNT OBLITERATION FOR RECURRENT HEPATIC ENCEPHALOPATHY." COMPLAINT FILES (B)(4). (B)(4) CAPTURES 2 CASES OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 74 YEAR OLD MALE. (B)(4) CAPTURES 1 CASE OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 57 YEAR OLD MALE. (B)(4) CAPTURES 2 CASES OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 75 YEAR OLD FEMALE. (B)(4) CAPTURES 1 CASE OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 74 YEAR OLD MALE. (B)(4) CAPTURES 1 CASE OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 47 YEAR OLD MALE. (B)(4) CAPTURES 1 CASE OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 66 YEAR OLD FEMALE. (B)(4) CAPTURES 1 CASE OF OFF-LABEL USE INVOLVING THE ECHO-19 NEEDLE TO INJECT GLUE WITH/OUT COILS IN A 50 YEAR OLD MALE. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: THE INSTRUCTIONS FOR USE (IFU0101), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER THAT "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THE USER IS INSTRUCTED AS PER (IFU0101) WHICH ACCOMPANIES THIS DEVICE UNDER THE POTENTIAL ADVERSE EVENTS "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY: ACUTE PANCREATITIS, ALLERGIC REACTION TO MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, PAIN/DISCOMFORT, PERFORATION, PERITONITIS, RESPIRATORY DEPRESSION OR ARREST, TUMOR SEEDING (THROUGH THE NEEDLE TRACT). THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0101). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE ECHO-19 DEVICE WAS USED IN A PROCEDURE WHERE ENDOSCOPIC ULTRASOUND-GUIDED TRANSGASTRIC SHUNT OBLITERATION WAS PERFORMED BY INJECTING GLUE AND COILS DIRECTLY INTO SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSS). IT WAS CONFIRMED BY OUR MEDICAL ADVISOR THAT USE OF THE COOK NEEDLE TO INJECT GLUE WITH/OUT COILS IS OFF-LABEL USE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, (B)(6), 2023- OFF LABEL USE 74/MALE CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT EXPERIENCED A SELF-LIMITED FEVER. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE ECHO-19 DEVICE WAS USED IN A PROCEDURE WHERE ENDOSCOPIC ULTRASOUND-GUIDED TRANSGASTRIC SHUNT OBLITERATION WAS PERFORMED BY INJECTING GLUE AND COILS DIRECTLY INTO SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSS). IT WAS CONFIRMED BY OUR MEDICAL ADVISOR THAT USE OF THE COOK NEEDLE TO INJECT GLUE WITH/OUT COILS IS OFF-LABEL USE.

    Description of Event or Problem · 0

    THE COMPLAINT WAS OPENED FOR 1 OFF LABEL EXPERIENCE OF USING COOK NEEDLE TO INJECT GLUE WITH/OUT COILS. RATHI, 2023 ¿ ENDOSCOPIC ULTRASOUND-GUIDED TRANSGASTRIC SHUNT OBLITERATION FOR RECURRENT HEPATIC ENCEPHALOPATHY. EUS-GUIDED TRANSGASTRIC SHUNT OBLITERATION WAS PERFORMED BY INJECTING GLUE AND COILS DIRECTLY INTO SPONTANEOUS PORTOSYSTEMIC SHUNTS (SPSS). EUS-GUIDED TRANSGASTRIC SHUNT OBLITERATION WAS PERFORMED FOR 7 PATIENTS IN 9 SESSIONS. WITH THE PATIENT IN THE LEFT LATERAL POSITION UNDER CONSCIOUS SEDATION WITH MIDAZOLAM/FENTANYL, A LINEAR ECHOENDOSCOPE (OLYMPUS GF-UCT180) WAS PLACED AT THE GASTRIC CARDIA AND SPLENOPORTAL AXIS TRACED FROM PORTAL TO SPLENIC END. THE AFFERENT OF THE SHUNT FROM THE SPLENOPORTAL AXIS WAS IDENTIFIED AT ITS TAKE-OFF. THE SHUNT WAS THEN TRACED TOWARD THE SYSTEMIC END AND A SUITABLE SITE SLIGHTLY PORTOFUGAL TO THE ORIGIN OF THE SHUNT MARKED AS TARGET FOR EMBOLIZATION. THIS SITE WAS THEN PUNCTURED WITH A 19-GAUGE EUS NEEDLE (ECHOTIP; COOK MEDICAL, BLOOMINGTON, IN OR EZSHOT3; OLYMPUS, MIAMI, FL) AND OCCLUDED USING UNDILUTED N-BUTYL-2-CYANOACRYLATE GLUE (ENDOCRYL; SAMARTH LIFE SCIENCES, MUMBAI, INDIA) WITH OR WITHOUT EMBOLIZATION COILS (NESTER; COOK MEDICAL). THIS COMPLAINT CAPTURES THE OFF-LABEL USE OF THE ECHO-19 NEEDLE. THE NEEDLE WAS USED IN EUS-GUIDED TRANSGASTRIC SHUNT OBLITERATION, PERFORMED BY INJECTING GLUE AND COILS DIRECTLY INTO SPSS. PATIENT OUTCOME - FEVER: SELF-LIMITED.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 05-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164962 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male