BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 15667539 · Received October 25, 2022

    Report

    Report Number
    3001845648-2022-00730
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    February 17, 2022
    Report Date
    December 2, 2022
    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 510K #K210476. DEVICE EVALUATION: THE ECHO-19 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT FILE WAS 1 OUT OF 4 OPENED FROM THE ZHANG ET. AL, 2022 LITERATURE PAPER IN RELATION TO THE OFF LABEL USE OF 45 ECHO-19 DEVICES OF UNKNOWN LOT NUMBER. PR (B)(4). (REPORT REFERENCE NUMBER (B)(4) ): ZHANG ET AL 2022 - 45 CASES OF OFF LABEL USAGE OF CST. PR (B)(4) (REPORT REFERENCE NUMBER (B)(4) ): ZHANG ET AL 2022 - 44 CASES OF OFF LABEL USAGE OF UNKNOWN ZIMMON BILIARY STENT. PR (B)(4). (REPORT REFERENCE NUMBER (B)(4) ): ZHANG ET AL 2022 - 1 CASE OF 'STENT OCCLUSION' AND OFF LABEL USAGE OF UNKNOWN ZIMMON BILIARY STENT. PR (B)(4) (REPORT REFERENCE NUMBER (B)(4) ): - ZHANG ET AL 2022 - 45 CASES OF OFF LABEL USAGE OF ECHO-19. LAB EVALUATION: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBERS ARE UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THERE WAS 45 CASES OF ECHO-19 AS CONTRAST MEDIUM WAS INJECTED TO EVALUATE THE OBSTRUCTION SITE. A 0.035-INCH GUIDEWIRE WAS INSERTED THROUGH THE PUNCTURE NEEDLE WHICH WOULD BE CONSIDERED OFF LABEL USE. (IFU0101). OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD BE ATTRIBUTED TO OFF-LABEL USE AS THERE WAS 15 CASES OF ECHO-19 AS CONTRAST MEDIUM WAS INJECTED TO EVALUATE THE OBSTRUCTION SITE. A 0.035-INCH GUIDEWIRE WAS INSERTED THROUGH THE PUNCTURE NEEDLE WHICH WOULD BE CONSIDERED OFF LABEL USE, AS PER IFU0101 "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE." SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510 K # K210476. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 02-DEC-2022.

    Description of Event or Problem · 0

    ZHANG ET AL 2022, APPLICATION OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY COMBINED WITH ANTEGRADE STENTING IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION AFTER FAILED ERCP. THIS STUDY WAS AIMED AT COMPARING THE SAFETY AND EFFECTIVENESS OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) AND EUS-HGS COMBINED WITH ANTEGRADE STENTING (EUS-HGAS) IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION (MBO) AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). PATIENTS DIAGNOSED WITH MBO AND RECEIVING EUS-HGS OR EUS-HGAS FROM SEPTEMBER 2015 TO OCTOBER 2020 WERE ENROLLED IN THIS STUDY. TOTAL 45 PATIENTS. 1. EUS-HGAS GROUP: 21 PATIENTS (18 MALE, AVG AGE 66 YRS) 2. EUS-HGS GROUP: 24 PATIENTS (20 MALE, AVG AGE 69 YRS) EUS-HGS COMBINED WITH ANTEGRADE STENTING (EUS-HGAS): THE GUIDEWIRE WAS INTRODUCED INTO THE BILE DUCT AND MANIPULATED TO PASS THE STRICTURE. AN UNCOVERED SELF-EXPANDABLE METAL STENT (SEMS) (MTN-DA-S-8/80-2.7/1800, MICRO-TECH, NANJING, CHINA) WAS DEPLOYED ACROSS THE STRICTURE, WHICH WAS CALLED EUS-AS. AFTER THAT, A DOUBLE PIGTAIL PLASTIC STENT (7 FR, ZIMMON BILIARY STENT, COOK IRELAND LTD., LIMERICK, IRELAND) OR A NASOBILIARY TUBE (7 FR, NBDS-A-7/250-P, MICRO-TECH, NANJING, CHINA) WAS INSERTED BETWEEN THE LEFT HEPATIC BILE DUCT AND THE STOMACH. IF THE GUIDEWIRE FAILED TO PASS THE STRICTURE OR IF PATIENTS COULD NOT TOLERATE A LONG OPERATION BECAUSE OF SERIOUS ILL-NESS OR ADVANCED AGE, THE FIRST-STEP PROCEDURE ENDED AFTER INSERTING A NASOBILIARY DUCT INTO THE LEFT HEPATIC BILE DUCT. AFTER APPROXIMATELY ONE WEEK, INSERTION OF ANOTHER BILIARY DRAINAGE TUBE WAS ATTEMPTED. FIRST, THE NASOBILIARY TUBE WAS WITHDRAWN AND THEN THE GUIDEWIRE WAS INSERTED INTO THE HEPATIC TUBE ALONG AN ERCP CONTRAST CATHETER (7 FR, PR-104Q-1, OLYMPUS, TOKYO, JAPAN). SIMILAR TO THE PREVIOUS PROCEDURE, THE SEMS WAS INSERTED ACROSS THE STRICTURE AND A PLASTIC STENT OR NASOBILIARY TUBE WAS INSERTED ACROSS THE SINUS TRACT. IF THE NASOBILIARY TUBE WAS INSERTED INTO THE SINUS, AFTER CONFIRMING SMOOTH BILIARY DRAINAGE FOR SEVERAL DAYS (USUALLY FOR 1 WEEK), THE TUBE WAS CUT ENDOSCOPICALLY. ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS): AFTER PUNCTURE INTO THE BILE DUCT, A PLASTIC STENT OR A NASOBILIARY TUBE WAS INSERTED INTO THE SINUS TRACT. PATIENTS WHO FAILED TWO-STEP EUS-HGAS WERE ALSO ENROLLED IN THIS GROUP. IN OTHER WORDS, IF THE GUIDEWIRE COULD NOT PASS THE STRICTURE EVEN WITH SKILLED GUIDEWIRE MANIPULATION, EUS-HGS WAS PERFORMED BY INSERTING EITHER A PLASTIC STENT OR A NASOBILIARY TUBE ACROSS THE SINUS TRACT. THIS FILE WILL CAPTURE THE 45 CASES OF OFF LABEL USAGE ECHO-19 FOR PUNCTURE. NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2895832 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male