BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 16918286 · Received May 12, 2023

    Report

    Report Number
    3001845648-2023-00366
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Report Date
    September 26, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA 510K# K210476. DEVICE EVALUATION: THE DEVICE EVALUATION OF THE ECHO-HD-22-C DEVICE OF UNKNOWN LOT NUMBER COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE FOLLOWING COMPLAINT FILES WERE OPENED AS A RESULT OF THIS PAPER, "BANG 2021 - COMPARING NEEDLES AND METHODS OF ENDOSCOPIC ULTRASOUND¿ GUIDED FINE-NEEDLE BIOPSY TO OPTIMIZE SPECIMEN QUALITY AND DIAGNOSTIC ACCURACY FOR PATIENTS WITH PANCREATIC MASSES IN A RANDOMIZED TRIAL". MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. REVIEW HISTORICAL DATA: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" AND "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE MIGHT BE DUE TO THE NEEDLES ENCOUNTERING A HARD SOLID MASS/ LESION AT PUNCTURE RESULTING IN THE NEEDLE BREAKS. IT IS STATED THAT THE PATIENTS HAD SUSPECTED SOLID PANCREATIC MASSES. HOWEVER, AS THE DEVICES WERE NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT INFORMATION INDICATED THAT THE ISSUE WAS BROKEN NEEDLE BUT WAS NOT SPECIFIC AS TO IT BEING A DISTAL OR PROXIMAL BREAK, SO AN ANALYSIS FOR THE LAST 3 YEARS OF ECHO TIP PROCORE HIGH-DEFINITION ULTRASOUND BIOPSY NEEDLE COMPLAINTS WAS CARRIED OUT TO DETERMINE WHICH IS THE MOST COMMON TYPE OF ISSUE. THE ANALYSIS DETERMINED THAT THIS WAS A DISTAL NEEDLE BREAK, THEREFORE AS THIS IS THE MOST COMMON FAILURE MODE THIS WAS SELECTED FOR THIS FILE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, NO HARM WAS ASSOCIATED WITH BROKEN NEEDLES REPORTED. CONFIRMED QUANTITY OF 03 DEVICES, CONFIRMED USED. INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE MIGHT BE DUE TO THE NEEDLES ENCOUNTERING A HARD SOLID MASS/ LESION AT PUNCTURE RESULTING IN THE NEEDLE BREAKS. IT IS STATED THAT THE PATIENTS HAD SUSPECTED SOLID PANCREATIC MASSES. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    LINEAR ARRAY ECHOENDOSCOPE (OLYMPUS GF-UCT180; OLYMPUS AMERICA, INC, CENTER VALLEY, PA) AFTER ADMINISTRATION OF PROPOFOL USING 1 OF 4 FNB (22G) NEEDLES (PROCORE; COOK ENDOSCOPY, WINSTON-SALEM, NC; EZ SHOT 3 PLUS; OLYMPUS AMERICA, INC; ACQUIRE; BOSTON SCIENTIFIC CORPORATION, MARLBOROUGH, MA; OR SHARKCORE; MEDTRONIC, SUNNYVALE, CA) BY 1 OF 4 EXPERIENCED ENDOSONOGRAPHERS (>750 EUS PROCEDURES/Y). THE 4 NEEDLE-TIP DESIGNS ARE SHOWN IN SUPPLEMENTARY FIGURE 1 AND THEIR GEOMETRIES ARE DESCRIBED IN THE SUPPLEMENTARY APPENDIX. DURING EUS FNB, THE STYLET WAS REMOVED AFTER PUNCTURING THE PANCREATIC MASS, AND SAMPLED USING THE FANNING TECHNIQUE (4 STROKES AT 4 LOCATIONS WITHIN THE MASS) (SUPPLEMENTARY VIDEO 1). DETAILS OF INDIVIDUAL SAMPLING TECHNIQUES ARE INCLUDED IN THE SUPPLEMENTARY APPENDIX. THREE DEDICATED PASSES WERE PERFORMED USING THE ASSIGNED NEEDLE: 1 PASS FOR EACH OF THE 3 TECHNIQUES, WITH THE ORDER OF THE TECHNIQUE DETERMINED BY THE RANDOMIZATION SEQUENCE. THE TISSUE SPECIMENS FROM EACH PASS WERE COLLECTED SEPARATELY IN 10% FORMALIN FOR TISSUE ANALYSIS. DETAILS ON THE METHOD OF TISSUE PREPARATION AND HISTOLOGIC ASSESSMENT ARE INCLUDED IN THE SUPPLEMENTARY APPENDIX. TO LIMIT SUBJECTIVE INTERPRETATION, SPECIMENS WERE QUANTIFIED USING SPECIALIZED IMAGE ANALYZING SOFTWARE (NIKON DS-FI2 COLOR CAMERA AND NIS-ELEMENTS BASIC RESEARCH SOFTWARE VERSION 4.5; NIKON INSTRUMENTS, INC, MELVILLE, NY) THAT MEASURED THE TOTAL SPECIMEN AREA, CORE TISSUE (ACINAR AND DUCTAL CELLS, FIBROSIS, AND TUMOR WHEN APPLICABLE), BLOOD, AND CRUSH ARTIFACT.6,7 THIS BASIC RESEARCH IMAGING SOFTWARE HAS BEEN USED PREVIOUSLY IN OTHER MEDICAL SPECIALTIES TO EVALUATE AND QUANTIFY TISSUE MORPHOLOGY.14¿16 IMMEDIATE ADVERSE EVENTS WERE DOCUMENTED AT THE TIME OF THE PROCEDURE AND LATE ADVERSE EVENTS BY TELEPHONE FOLLOW-UP EVALUATION AT 7 AND 30 DAYS AFTER THE PROCEDURE. THIS COMPLAINT CAPTURES 3 CASES OF BROKEN NEEDLE DURING FNB.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26-SEP-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352214 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male