BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 14019087 · Received April 6, 2022

    Report

    Report Number
    3001845648-2022-00199
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    October 7, 2021
    Report Date
    January 10, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002520124
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ECHO-HD-19-A DEVICE OF LOT NUMBER C1808244 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14TH JAN 2021. ON EVALUATION OF THE FOLLOWING WERE OBSERVED. VISUAL INSPECTION: STYLET EXPOSED AND CAP MISSING. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. DISTAL END OF NEEDLE EXAMINED , NO ISSUE OBSERVED. STYLET REMOVED WITH DIFFICULTY. RE EVALUATED 10 MAR 2022. PROXIMAL NEEDLE BREAK OBSERVED BELOW THE SHEATH EXTENDER. DOCUMENT REVIEW PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-19-A OF LOT NUMBER C1808244 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1808244. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0050-2 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 NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0050-2). AS PER RELEVANT PROCEDURES ¿ STEP 7 ¿¿ CHECK TO ENSURE THAT THE STYLET WIRE OPERATES SMOOTHLY'' '' NOTE: FOR ECHO-HD-19-A: WHEN RE-INSERTING THE STYLET, ENSURE THAT THE STYLET CAP IS TIGHTEN MANUALLY WITHOUT USING EXCESSIVE FORCE.'' ¿ STEP 4.18 ''FEED THE NEEDLE THROUGH THE HANDLE AND INTO THE DEVICE ¿ APPROXIMATELY HALF WAY'' A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE DEVICE BEING USED IN A FLEXED POSITION. IT IS POSSIBLE THAT AT SOME POINT DURING THE PROCEDURE THE NEEDLE MAY HAVE BECAME STUCK AND ON ATTEMPTING TO REMOVE THE STYLET FROM THE NEEDLE THE CAP DETACHED , SUBSEQUENTLY CAUSING THE NEEDLE BREAK. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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

    DEVICE EVALUATION: THE ECHO-HD-19-A DEVICE OF LOT NUMBER C1808244 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14 JAN 2021. ON EVALUATION OF THE THE FOLLOWING WERE OBSERVED. VISUAL INSPECTION: STYLET EXPOSED AND CAP MISSING. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. DISTAL END OF NEEDLE EXAMINED , NO ISSUE OBSERVED. STYLET REMOVED WITH DIFFICULTY. RE EVALUATED 10 MAR 2022 PROXIMAL NEEDLE BREAK OBSERVED BELOW THE SHEATH EXTENDER. DOCUMENT REVIEW PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-19-A OF LOT NUMBER C1808244 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1808244. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0050 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 NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0050). ROOT CAUSE REVIEW A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE DEVICE BEING USED IN A FLEXED POSITION. IT IS POSSIBLE THAT AT SOME POINT DURING THE PROCEDURE THE NEEDLE MAY HAVE BECAME STUCK AND ON ATTEMPTING TO REMOVE THE STYLET FROM THE NEEDLE THE CAP DETACHED , SUBSEQUENTLY CAUSING THE NEEDLE BREAK. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.

    Description of Event or Problem · 0

    THIS IS A COMBINED INITIAL AND FINAL REPORT. THE PLASTIC HUB ON THE END OF THE STYLET DROPPED UPON TRYING TO WITHDRAW THE STYLET ONCE THE NEEDLE HAS ALREADY PUNCTURED THE PSEUDOCYST. THE STYLET WAS REPORTED TO BE STUCK INSIDE THE DEVICE AND NOT ABLE TO BE USED AFTER THE FIRST PUNCTURE, THE NEEDLE WAS THEN WITHDRAWN AND A COMPETITOR FNA NEEDLE WAS USED INSTEAD & IT WAS SUCCESSFUL. COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON 14-JAN-2022: STYLET EXPOSED AND CAP MISSING. COMPLAINT DEVICE WAS RE-EVALUATED ON 10-MAR-2022: PROXIMAL NEEDLE BREAK OBSERVED BELOW THE SHEATH EXTENDER. DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO/ DID THE COMPLAINANT INFORM OF ANY ADVERSE EFFECT(S) ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE COMPLAINANT INFORM THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECT(S)? NO.

    Description of Event or Problem · 0

    CORRECTION REPORT IS BEING SENT AS A CODE AND G CODE HAVE BEEN UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444241 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1808244 10827002520124

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male